25155 Rye Canyon Loop Valencia CA USA. Boston Scientific Limited. Ballybrit Business Park Galway IRELAND

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1 EC Certificate EC Design-Examination Certificate Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD), Annex 2 (4) (Other devices than custom made or intended for clinical investigation) No Product Service Manufacturer: Boston Scientific Neuromodulation Corporation Rye Canyon Loop Valencia CA USA E C -Re prese ntative: Boston Scientific Limited Ballybrit Business Park Galway IRELAND Product: Implantable Neurostimulator Systems The Certification Body of TOV SOD Product Service GmbH declares that a design examination has been carried out on the respective devices in accordance with AIMDD Annex 2 (4). This design of the devices conforms to the requirements of this Directive. For marketing of these devices an additional Annex 2 certificate is mandatory. See also notes overleaf. Report no.: Valid from: Valid until: Date, Hans-Heiner Junker TOV SOD Product Service GmbH is Notified Body with identification no Page 1 of 2 TUV SUO Product Service GmbH. Zertifizierstelle. Ridlerstral3e Munchen. Germany

2 EC Certificate EC Design-Examination Certificate Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD), Annex 2 (4) (Other devices than custom made or intended for clinical investigation) No Model(s): see attachment Parameters:.I. Facility(ies): Boston Scientific Neuromodulation Corporation Rye Canyon Loop, Valencia CA 91355, USA Design Facility(ies): Boston Scientific Neuromodulation Corporation Rye Canyon Loop, Valencia CA 91355, USA Page 2 of 2 TUV SUO Product Service GmbH. Zertifizierstelle. RidlerstraBe Mlinchen. Germany 1tJV

3 Product: Implantable Neurostimulator Systems Test Report No.: 7011S238 Precision External Trial Stimulator Precision Remote Control Precision Base Station xx cm 8 Contact Extension Clinician Programmer with Bionic NAVIGATOR Software SC-S110 SC-S210 SC-S30S SC-3138-xx SC-71S0 Test Report No.: Precision Passing Elevator SC-4230 Test Report No.: Precision Charger SC-S312 Test Report No.: Precision OMG Connector-A Precision OMG Connector-M SC-930S SC-9310 Test Report No.: Clinician Programmer with Bionic NAVIGATOR Software SC-71S0-4 Page 1 of 4 TUV SUO Product Service GmbH. Zertifizierstelle. Ridlerstra~e MLinchen. Germany TUV '

4 Test Report No.: Linear xx cm 8 Contact Lead Kit SC-2158-xx Test Report No.: Medical Adhesive SC-4320 Test Report No.: Precision Implantable Pulse Generator Kit SC Test Report No.: Linear STTM xx cm 8 Contact Lead Kit Test Report No. : Precision Connector M 1 SC-2218-xx SC-9004-xx Test Report No. : Artisan xx cm 2x8 Surgical Lead SC-8216-xx Page 2 of 4 TUV SUO Product Service GmbH. Zertifizierstelle. Ridlerstral5e Munchen. Germany

5 Test Report No.: Introducer SC-4365 Test Report No.: Precision Remote Control SC-5212 Test Report No. : xx em W4 Splitter 2x4 xx em 04 Splitter 2x4 SC-3354-xx SC-3304-xx Test Report No.: Linear 3-4 xx em 8 Contact Lead Kit Linear 3-6 xx em 8 Contact Lead Kit SC-2352-xx SC-2366-xx xx denotes length Test Report No.: Charger Belt SC-6358-xxx xxx denotes size and color Page 3 of 4 TUV SUD Product Service GmbH. Zertifizierstelie. Ridlerstr a ~e MUnchen. Germany luv '

6 Test Report No.: Linear xx cm 8 Contact Trial Lead Kit Linear STTM xx cm 8 Contact Trial Lead Kit Linear 3-4 xx cm 8 Contact Trial Lead Kit Linear 3-6 xx cm 8 Contact Trial Lead Kit SC-2158-xxE SC-2218-xxE SC-2352-xxE SC-2366-xxE xx denotes length Test Report No. : Clik Anchor Clik Anchor Hex Wrench, 7.6cm SC-4316 SC-4276 Test Report No. : Infinion 16 xx cm 16 Contact Lead Kit Infinion 16 xx cm 16 Contact Trial Lead Kit xx cm Splitter 2x8 Kit SC-2316-xx SC-2316-xxE SC xx Test Report No. : Precision Implantable Pulse Generator Precision External Trial Stimulator Precision Remote Control Clinician Programmer with Bionic NAVIGATOR (HR) Software Munich, CRT2, ~ Hans-Heiner Junker Certification Medical Technology SC-1112 SC-5112 SC-5213 NM Page 4 of 4 TOV SOD Product Service GmbH. Zertifizierstelie. Ridlerstral3e MOnchen. Germany luv '