Q4D-SC1132SC-1132

Indications for Use Indications for Use 90668223-01 Rev A 1 of 2 Indications for Use The Boston Scientifi c Precision Spectra™ Spinal Cord Stimulator System (Precision Spectra System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. Refer to the Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, Physician Instructions, sterilization, component disposal, contact information for Boston Scientifi c, information regarding the Patient Identifi cation card, FCC rules and clinical studies supporting clinical use of the neuromodulation system. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Indications for Use Indications for Use 90668223-01 Rev A 2 of 2 Boston Scientifi c Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355, USA 866.360.4747 in US and Canada +1 661.949.4747 Phone +1 661.949.4022 Fax 866.789.6364 TTY www.bostonscientifi c.com Email: [email protected] © 2012 Boston Scientifi c Corporation or its affi liates. All rights reserved. 90668223-01 Rev A 2012-04

PRECISION SPECTRA™ SYSTEMINFORMATION FOR PATIENTS Part No. 90668560-01 Rev B This page intentionally left blank. Information for Patients CAUTION:Federal law restricts this device to sale, distribution and use by or on the order of a physician. Part No. 90668560-01 Rev B Information for PatientsPrecision Spectra™ System Information for Patients90668560-01 Rev B ii of iiCopyright©2012 Boston Scienti fi c Corporation or its af fi liates. All Rights Reserved. These documents are the property of Boston Scienti fi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scienti fi c Corporation.GuaranteesBoston Scienti fi c reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity.Drawings are for illustration purposes only.Refer to the Precision Spectra™ System Patient Trial Handbook, Precision Spectra System Remote Control Handbook, Charger Handbook, and Limited Warranty for additional instructions and information on your Spinal Cord Stimulation System. Precision Spectra™ System Information for Patients 90668560-01 Rev B 1 of 32 Table of Contents Safety Information .................................................................................................2 Indications for Use ........................................................................................................... .............2 Precision Spectra System Clinical Summary ................................................................................2 Table 1: Summary of Risks Identi fi ed in the Retrospective Clinical Studies ..............................7 Table 2: Clinical Experience Safety ........................................................................................... 8 Contraindications ............................................................................................................. ...........10 Warnings ...................................................................................................................... ...............10 Precautions ................................................................................................................... ..............13 Adverse Effects ............................................................................................................... ............17 FCC Rules ............................................................................................................................... ....19 Patient Identi fi cation Card ...........................................................................................................20 End of Programmed Service ..................................................................................................... ..20 IPG Battery Life............................................................................................................... .............21 Contacting Boston Scienti fi c .............................................................................22 Glossary ...............................................................................................................23 Precision Spectra™ System Information for Patients90668560-01 Rev B 2 of 32 Safety InformationIndications for UseThe Boston Scienti fi c Precision Spectra™ Spinal Cord Stimulator System (Precision System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.Precision Spectra System Clinical SummaryDetermination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra System is similar to the SCS systems reported in published literature in intended use, target patient population, technology, device design, and output characteristics. Therefore, the clinical data from the published literature described below represents evidence supporting the safety and effectiveness of the Precision Spectra System for the treatment chronic intractable pain of the 1 Safety Information Precision Spectra™ System Information for Patients 90668560-01 Rev B 3 of 32 trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.Ef fi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al. 1995). The studies included a total of 116 patients that were implanted with an SCS system. A total of approximately 3166 device months of experience was depicted from the retrospective clinical evaluation. All three studies examined the effectiveness of SCS on patients with chronic pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and leg pain. In all studies, a totally implantable spinal cord stimulator was used in association with a percutaneous and/or surgical lead. These studies provide the same diagnostic or therapeutic intervention for the same disease/conditions and patient population as the Precision Spectra System.The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients with intractable leg pain. Forty patients were implanted with SCS systems and evaluated at 6 weeks, 12 months, and 24 months follow-up. Outcome measures included the VAS, pain drawings, medication use, SIP (Sickness Impact Pro fi le), isometric lower extremity testing, and patient questionnaires. An intent-to-treat analysis was performed. After patients had SCS for 24 months, Informati…

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CAUTION: Federal law restricts this device to sale, distribu- tion and use by or on the order of a physician. Precision Spectra™ System Information for Prescribers 90668515-01 REV A Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A ii of iv Copyright © 2012 Boston Scientifi c Corporation or its affi liates. All Rights Reserved. These docu- ments are the property of Boston Scientifi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientifi c Corporation. Guarantees Boston Scientifi c Corporation reserves the right to modify, without prior notice, infor- mation relating to its products in order to improve their reliability or operating capacity. Trademarks Precision Spectra is a trademark of Boston Scientifi c. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Table of Contents Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iii of iv Refer to the Indications for Use for indications and related information. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Table of Contents Device and Product Description .................................................................. 1 Precision Spectra System Clinical Summary........................................................ 1 Contraindications ........................................................................................... 6 Safety Information .......................................................................................... 6 Instructions for the Patient ..................................................................................................6 Adverse Effects ................................................................................................................. 10 Instructions for the Physician ............................................................................................ 11 Sterilization ....................................................................................................................... 12 FCC Rules.......................................................................................................13 Technical Service...........................................................................................13 End of Programmed Service........................................................................14 IPG Battery Life.............................................................................................14 Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iv of iv This page intentionally left blank. Device and Product Description Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 1 of 15 Device and Product Description The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and Programming Wand, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits. Features of the Precision Spectra System include: • Stimulation electrode fi eld navigation • Thirty-two independent current-controlled electrodes • Four programmable stimulation areas per program; sixteen possible programs • Long-life operation • High-range parameter capability • Small size • Two-foot programming range • This product contains no detectable latex Precision Spectra System Clinical Summary Determination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra System is similar to the SCS systems reported in published literature in intended use, target patient population, technology, device design, and output characteristics. Therefore, the clinical data from the published literature described below represents evidence supporting the safety and effectiveness of the Precision Spectra System for the treatment chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Effi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al. 1995). The studies included a total of 116 patients that were implanted with an SCS system. A total of approximately 3166 device months of experience was depicted from the retrospective clinical evaluation. All three studies examined the effectiveness of SCS on patients with chronic pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and leg pain. In all studies, a totally implantable spinal cord stimulator was used in association with a percutaneous and/or surgical lead. These studies provide the same diagnostic or therapeutic intervention for the same disease/conditions and patient population as the Precision Spectra System. Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 2 of 15 The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients with intractable leg pain. Forty patients wer…

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Indications for Use Indications for Use 90668223-01 Rev A 1 of 2 Indications for Use The Boston Scientifi c Precision Spectra™ Spinal Cord Stimulator System (Precision Spectra System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. Refer to the Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, Physician Instructions, sterilization, component disposal, contact information for Boston Scientifi c, information regarding the Patient Identifi cation card, FCC rules and clinical studies supporting clinical use of the neuromodulation system. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Indications for Use Indications for Use 90668223-01 Rev A 2 of 2 Boston Scientifi c Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355, USA 866.360.4747 in US and Canada +1 661.949.4747 Phone +1 661.949.4022 Fax 866.789.6364 TTY www.bostonscientifi c.com Email: [email protected] © 2012 Boston Scientifi c Corporation or its affi liates. All rights reserved. 90668223-01 Rev A 2012-04

CAUTION: Federal law restricts this device to sale, distribu- tion and use by or on the order of a physician. Precision Spectra™ System Information for Prescribers 90668515-01 REV A Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A ii of iv Copyright © 2012 Boston Scientifi c Corporation or its affi liates. All Rights Reserved. These docu- ments are the property of Boston Scientifi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientifi c Corporation. Guarantees Boston Scientifi c Corporation reserves the right to modify, without prior notice, infor- mation relating to its products in order to improve their reliability or operating capacity. Trademarks Precision Spectra is a trademark of Boston Scientifi c. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Table of Contents Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iii of iv Refer to the Indications for Use for indications and related information. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Table of Contents Device and Product Description .................................................................. 1 Precision Spectra System Clinical Summary........................................................ 1 Contraindications ........................................................................................... 6 Safety Information .......................................................................................... 6 Instructions for the Patient ..................................................................................................6 Adverse Effects ................................................................................................................. 10 Instructions for the Physician ............................................................................................ 11 Sterilization ....................................................................................................................... 12 FCC Rules.......................................................................................................13 Technical Service...........................................................................................13 End of Programmed Service........................................................................14 IPG Battery Life.............................................................................................14 Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iv of iv This page intentionally left blank. Device and Product Description Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 1 of 15 Device and Product Description The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and Programming Wand, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits. Features of the Precision Spectra System include: • Stimulation electrode fi eld navigation • Thirty-two independent current-controlled electrodes • Four programmable stimulation areas per program; sixteen possible programs • Long-life operation • High-range parameter capability • Small size • Two-foot programming range • This product contains no detectable latex Precision Spectra System Clinical Summary Determination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra System is similar to the SCS systems reported in published literature in intended use, target patient population, technology, device design, and output characteristics. Therefore, the clinical data from the published literature described below represents evidence supporting the safety and effectiveness of the Precision Spectra System for the treatment chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Effi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al. 1995). The studies included a total of 116 patients that were implanted with an SCS system. A total of approximately 3166 device months of experience was depicted from the retrospective clinical evaluation. All three studies examined the effectiveness of SCS on patients with chronic pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and leg pain. In all studies, a totally implantable spinal cord stimulator was used in association with a percutaneous and/or surgical lead. These studies provide the same diagnostic or therapeutic intervention for the same disease/conditions and patient population as the Precision Spectra System. Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 2 of 15 The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients with intractable leg pain. Forty patients wer…

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CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. 90655621-03 REV A Precision Spectra™ System Implantable Pulse Generator Directions for Use SC-1132 Implantable Pulse Generator Implantable Pulse Generator Implantable Pulse Generator 90655621-03 Rev A ii of iv Copyright © 2011 Boston Scientifi c Corporation or its affi liates. All Rights Reserved. These documents are the property of Boston Scientifi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientifi c Corporation. Guarantees Boston Scientifi c Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks Precision Spectra and Infi nion are trademarks of Boston Scientifi c. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Table of Contents Implantable Pulse Generator 90655621-03 Rev A iii of iv Product Model Number SC-1132 Implantable Pulse Generator Refer to the Indications for Use for indications and related information. Refer to the appropriate Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, Physician instructions, sterilization, component disposal, and contact information for Boston Scientifi c. Refer to the Labeling Symbols Addendum for an explanation of labeling symbols. Refer to the following Directions for Use (DFU) for device specifi c instructions not included in this manual: Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra™ System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. For information regarding the Patient Identifi cation Card, FCC rules and for clinical studies supporting the clinical use of the neurostimulation system, refer to the Information for Prescribers manual. Table of Contents Description ...................................................................................................................... 1 Package Contents .......................................................................................................... 1 IPG Kit ......................................................................................................................... 1 Specifi cations and Technical Data ................................................................................ 3 Registration Information ................................................................................................ 3 Instructions for Use ........................................................................................................ 4 IPG Handling and Storage .......................................................................................... 4 Pre-Op Instructions ..................................................................................................... 4 IPG Implantation ......................................................................................................... 4 Tunneling the Lead or Lead Extension ....................................................................... 5 IPG Explant or Replacement....................................................................................... 9 Rechargeable Stimulator System ................................................................................. 9 Charging Steps ............................................................................................................. 10 WARNINGS: ............................................................................................................. 10 IPG Battery Status ........................................................................................................ 11 Implantable Pulse Generator Implantable Pulse Generator 90655621-03 Rev A iv of iv This page intentionally left blank. Description Implantable Pulse Generator 90655621-03 Rev A 1 of 11 Description The Precision Spectra™ Implantable Pulse Generator (IPG) system is intended to treat chronic pain by electrically stimulating the spinal cord. The multi-channel, multi-electrode device capability provides fl exibility in conjunction with ease of programming. A rechargeable battery increases IPG longevity and output capability while reducing size and device replacement surgeries. The IPG is controlled by a handheld Remote Control, and can be engaged by a clinician programmer using proprietary programming software. Periodically, the IPG battery requires replenishing with an external RF charging device. Package Contents IPG Kit (1) Precision Spectra Implantable Pulse Generator (1) Hex Wrench (1) Tunneling Tool Assembly (1) IPG Pocket Template (4) Port Plugs (1) Device Registration Form and Temporary Patient Identifi cation Card Implantable Pulse Generator Implantable Pulse Generator 90655621-03 Rev A 2 of 11 Maximum Current Amplitude per Electrode Versus Impedance Pulse Width: Current (mA) Impedance ( Ω ) Note: Maximum output capacity is frequency independent Programmable up to 25.5 mA Programmable up to 21.1 mA Programmable up to 15.8 mA Programmable up to 12.7 mA Specifi cations and Technical Data Implantable Pulse Generator 90655621-03 Rev A 3 of 11 Specifi cations and Technical Data ParameterRangeDefault Areas (Channels)4— Amplitude0 – 25.5 mA0 mA Rate2 – 1200 pps a 40 pps Width20 – 1000 μsec b 210 μsec Cycle 0.1 – 90 min, OFFOFF Ramp ON1 – 10 secs3 secs Contacts1 – 32, case: +100% to -100%, OFF1 – 32, case: OFF a. Only one Area is available if the rate is ≥130 pps. b. Amplitude × Width ≤ 12.7 μC. Materials CaseTitanium HeaderEpoxy Strain ReliefSilicone Size/Volume55.0 mm x 46.0 mm x 10.8 mm / 21.2 cm 3 (including header) Radiopaque…

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June 19, 2012 FCC ID: Q4D-SC1132 Dear Application Examiner: An application for a grant of equipment authorization for FCC ID Q4D-SC1132 was recently submitted. The applicant requested short term confidentiality with the intent that no photos of their product would be viewable by the public. It was realized after the fact that the test report that was uploaded contained photos of the device. An updated version of the report with the photos removed has been uploaded and should supersede the report that was originally submitted. Thank you.

IPG External Photo Side 1 IPG External Photo Side 2 IPG External Photo Side 3 IPG External Photo Side 4 IPG External Photo Side 5 IPG External Photo Side 6

IPG Internal Photo Side 2 IPG Internal Photo Side 1

Boston Scientific Neuromodulation Implantable Pulse Generator Model SC-1132 Report No. BOSN0010.3 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2011 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Test: May 24, 2011 Boston Scientific Neuromodulation Model: SC-1132 Emissions Test Description Specification Test Method Pass/Fail Field Strength of Fundamental FCC 15.209:2011 ANSI C63.10:2009 Pass Field Strength of Spurious Emissions FCC 15.209:2011 ANSI C63.10:2009 Pass Modifications made to the product See the Modifications section of this report Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 41 Tesla Ave. Irvine, CA 92618 Phone: (503) 844-4066 Fax: 844-3826 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834B-1). Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200676-0 This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 06/29/09 Barometric Pressure The recorded barometric pressure has been normalized to sea level. Revision Number Description Date Page Number 00 None Accreditations and Authorizations FCC Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in o…

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