Q4D-NM7190NM-7190

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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Northwest EMC TCB Compliance Opinion Rev. 7/1/10 BOSN0011 Information about the Applicant Grantee (Company Name) Boston Scientific Neuromodulation FCC Contact Person Kaoru Adair Address 25155 Rye Canyon Loop City, State, Zip Valencia, CA 91355 Job Number BOSN0011 Model NM7190 FCC ID Q4D-NM7190 Agent Approval Type Original Equipment Class DCD- Part 15 Low Power Transmitter Below 1705 kHz Rule Part 15.209 Overview This application is for the original approval of Boston Scientific Neuromodulation Corporation's model NM-7190 Programming Wand. The wand is a component of their Precision Spectra Spinal cord Stimulator and is used to provide a data link between the Clinician Programmer and the External Trial Stimulator or an implanted device (IPG). Confidentiality requested for allowed files. Request is properly addressed and referenced. Short term confidentiality requested for photos and manuals. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 6/11/2012

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

3. ARTWORK SHOWN ON WAND HOUSING FOR LOCATION ARE FOR REFERENCE ONLY. 2. FOR ARTWORK REQUIRED FOR LASER MARKING, ACQUIRE IMAGE FROM DOC CONTROL. SEE TABULATION BLOCK. 1. LASER MARK LABEL TO BE USED ON RF WAND HOUSING P/N 6045805. FONT: ARIAL / REGULAR / 6.5 PT. FONT: ARIAL / REGULAR / 6.5 PT. -001-002 DASH #REV.MASTER PATTERNREV. -001AMP6026386-001AA -002AMP6026386-002AA B EFFECTIVE DATED.C. NO.ECO ORIGINATOR N/A 1 of 1 11006 25155 Rye Canyon Loop Valencia, California 91355 (661) 949-4000 SURFACE FINISH PER ANSI-B46-1 BREAK ALL EDGES .005 -.012 MAX. DO NOT SCALE DRAWING SCALE SHEET TITLE SIZE DRAWING NUMBER REV SolidWorks DWG A 4 B C 321 A B C D 4321 D 16 OCT 2009 9196519 REV AJ PRODUCTION RELEASE AA AB ADDED -002 CONFIGURATION 19 APR 2010 27 JAN 2012 This document is and contains designs and/or other information that are the property of Boston Scientific Neuromodulation Corporation. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s)disclosed herein, or for any other purpose, without the prior written permission of Boston Scientific Neuromodulation Corporation. CONFIDENTIAL FILLET RADII .005 MAX. APPLICATION NEXT ASSY MODEL NO. DASH NO. N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A DESCRIPTION PRE-RELEASE REV 01 GINO MERCURIO GINO MERCURIO N/AN/A N/A 16 OCT 2009 6026386 AB LABEL, LASER MARK,RF WAND NOTES: UNLESS OTHERWISE SPECIFIED: 1107098 GINO MERCURIO 965601 90567224 BSN DRAFTING STANDARD APPLIES mm INCH X .X .XX .XXX CHECKED DRAWN DESIGNER APPROVALS UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES. .X .XX .XXX .XXXX .1 .01 .005 .0005 0.25 0.1 0.05 0.010 ANGLES 1 ENGINEER DATE TOLERANCES THIRD ANGLE PROJECTION FRACTION 1/32 (UNLESS OTHREWISE NOTED ON THE DRAWING) CAD DATABASE: SOLIDWORKS Boston Scientific GINO MERCURIO N/A N/A 32 N/A N/A N/A N/A

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Boston Scientific Neuromodulation Wand Model NM-7190 Report No. BOSN0010.4 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: NM-7190 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 AC Powerline Conducted Emissions FCC 15.207:2011 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 our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP Northwest EMC, Inc. is accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. NVLAP is administered by the National Institute of Standards and Technology (NIST), an agency of the U.S. Commerce Department. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 2004/108/EC, and ANSI C63.4. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. Industry Canada Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS-Gen, Issue 2 and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. (Site Filing Numbers - Hillsboro: 2834D-1, 2834D-2, Sultan: 2834C-1, Irvine: 2834B-1, 2834B-2, Brooklyn Park: 2834E-1) CAB Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. Australia/New Zealand The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA logo. Test reports made by an overseas laboratory that has been accredited for the relevant standards by an overseas accreditation body that has a Mutual Recognition Agreement (MRA) with NATA are also accepted as technical grounds for product conformity. The report should be endorsed with the respective logo of the accreditation body (NVLAP). Accreditations and Authorizations VCCI Accepted as an Associate Member to the VCCI, Acceptance No. 564. Conducted and radiated measurement facilities have been registered in accordance with Regulations for Voluntary Control Measures, Article 8. (Registration Numbers. - Hillsboro: C-1071, R-1025, G-84, C-2687, T- 1658, and R-2318, Irvine: R-1943, G-85, C-2766, and T-1659, Sultan: R-871, G-83, C-1784, and T-1511, Brooklyn Park: R-3125, G-86, G-141, C-3464, and T-1634). BSMI Northwest EMC has been designated by NIST and validated by C-Taipei (BSMI) as a CAB to conduct tests as described in the APEC Mutual Recognition Agreement (US0017). GOST Northwest EMC, Inc. has been assessed and accredited by the Russian Certification bodies Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC, to perform EMC and Hygienic testing for Information Technology Products. As a result of their laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification KCC Northwest EMC, Inc is a CAB designated by MRA partners and recognized by Korea. (Assigned Lab Numbers: Hillsboro: US0017, Irvine: US0158, Sultan: US0157, Brooklyn Park: US0175) VIETNAM Vietnam MIC has approved Northwest EMC as an accredited test lab. Per Decision…

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NORTHWEST EMC Field Strength of Fundamental PSA 2011.05.11 NORTHWEST EMC Field Strength of Fundamental PSA 2011.05.11 NORTHWEST EMC Field Strength of Fundamental PSA 2011.05.11 NORTHWEST EMC Field Strength of Spurious Emissions PSA 2011.05.11 NORTHWEST EMC Field Strength of Spurious Emissions PSA 2011.05.11 NORTHWEST EMC Field Strength of Spurious Emissions PSA 2011.05.11 NORTHWEST EMC IMG_0038.JPG IMG_0037.JPG AC Power Line Conducted Emissions PSA-ESCI 2010.04.06