Boston Scientific Corporation

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System EMBLEM S-ICD Subcutaneous Electrode EMBLEM S-ICD Electrode EMBLEM S-ICD Programmer EMBLEM S-ICD Pulse Generator EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD Electrode Delivery System EMBLEM S-ICD Electrode Insertion System EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD System Patient Screen Tool Log Data Card for the Model 3200 EMBLEM S-ICD Programmer Power Supply for S-ICD Programmer Tool Wand for SICD Programmer 3200 SQ-RX Pulse Generator AGENT Paclitaxel-Coated Balloon Catheter Ambicor AMS 700 with Inhibizone AMS 700 without Inhibizone Carotid WALLSTENT Monorail Endoprosthesis Epic Vascular Self-Expanding Stent System Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device Flextome Cutting Balloon Microsurgical Dilatation Device Apex Push PTCA Dilatation Catheter Apex PTCA Dilatation Catheter Express SD Renal/Biliary Premounted Stent System AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console INTELLAGEN Remote Control Connection Cable 30 Meter Cable IntellaTip MiFi XP Sterile Cable IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable IntellaTip MiFi Filter Module RF Frequency Filter IntellaTip MiFi XP Temperature Ablation Catheter Blazer Prime XP Temperature Ablation Catheter IntellaNav MiFi XP Temperature Ablation Catheter Electrophysiology Cable Non-Sterile Cable Blazer Solid-Tip Ablation Cather Cable, Sterile Cable Maestro 4000 RF Cardiac Ablation Controller Maestro 4000 RF Cardiac Ablation Pod 100 Maestro Foot Switch IntellaNav XP Temperature Ablation Catheter Maestro 4000 Remote Control Cable, IntellaNav Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Grounding Cable 3 Meter Non-Sterile Cable INTELLAGEN RF Generator Kit INTELLAGEN Remote Control Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Kit INTELLAGEN ECG Connection Cable 3 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Remote Control Connection Cable 15 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN Stylet INGEVITY MRI FORMIO MRI VITALIO MRI INGENIO MRI Suture Sleeve ESSENTIO MRI PROPONENT MRI ACCOLADE MRI Urovac Bladder Evacuator Precision Battery AAA 1.5 Alkaline Precision Charger Artisan Surgical Lead Kit Cable, USB Serial Precision Spectra Patient Trial Belt Precision Lead Blank O.R. Cable and Extension Precision Spectra External Trial Stimulator Precision AC/DC Power Supply Charger Belt Extension Precision Precision Spectra Remote Control Enhanced Steering Kit with Stylet Cap Introducer Remote Control Silicone Case Clik X MRI Anchor D4 Splitter Kit Spectra WaveWriter Implantable Pulse Generator and Charging Kit Precision Patient Trial Belt Linear 3-6 Lead Kit USB Splitter Power Unlimited, Power Adapter Precision Implantable Pulse Generator and Charging Kit Precision Adhesive Kit Clik X Anchor Precision Novi Implantable Pulse Generator Kit Precision IPG Port Plug Precision Lithium Manganese Dioxide Battery 6 Volts Precision Cable, USB-Serial Patient Trial Kit Linear 3-4 Lead Kit Spectra WaveWriter External Trial Stimulator Precision IRDA Dongle Holder Charger Spacer Precision Spectra IPG Port Plug Precision Patient Trial Kit Tablet Pen Charger Belt Loops Replacement Paddle Blank for CoverEdge 32 Surgical Lead Precision Connector Clinician Programmer Insertion Needle Precision OMG Connector-A Precision Primary Lithium Battery AA Type STD Precision Charging System Kit Precision Base Station Precision External Trial Stimulator Linear Precision Tablet PC Pen Spectra Implantable Pulse Generator and Charging Kit CoverEdge X 32 Surgical Lead Kit Splitter Kit Precision Passing Elevator Programming Wand Spectra Implantable Pulse Generator Kit Charger Belt Precision Epimed Needle Clik Anchor Hex Wrench Medical Adhesive Precision PC SC-7150 CoverEdge 32 Surgical Lead Kit Installer for BN3.1 Entrada Needle Precision Suture Sleeve Precision Remote Control Case Precision Charging Belt Precision Patient Controller Entrada Spare Sheath Precision Hex Wrench Precision S8 Adapter Precision OMG Connector-M Power Supply for Tablet Computer USB Power Supply Remote Control (U.S.) Precision Power Supply & Adapter For Charger Precision Clinician Programmer Stylet Kit with Stylet Cap Precision Spectra OMG Adapter Extension Kit Precision Montage MRI Implantable Pulse Generator Kit Precision Patient Programmer Kit Infinion Lead Kit W4 Splitter Kit Precision Holster Click Anchor Spectra External Trial Stimulator Linear ST Lead Kit Avista MRI Lead Kit Infinion CX Lead Kit Tunneling Tool SCS Implantable Materials Kit Linear Lead Kit Precision Spectra Remote Control Kit Spectra WaveWriter Implantable Pulse Generator Precision Spectra Implantable Pulse Generator Kit Paddle Blank for CoverEdge X 32 Surgical Lead Remote Control Holster Precision Implantable Pulse Generator Kit Precision Remote Control Artisan MRI Surgical Lead Kit Bionic Navigator 3D Installer Keyboard Precision Spectra Implantable Pulse Generator and Charging Kit Precision Spectra Patient Trial Kit Precision IR Interface Precision Montage MRI Implantable Pulse Generator and Charging Kit Precision Montage Implantable Pulse Generator Kit Precision M8 Adapter WaveWriter Alpha 16 IPG and Charging Kit CoverEdge X MRI 4x8 Surgical Lead Kit WaveWriter Alpha IPG and Charging Kit Pairing Magnet WaveWriter Alpha ETS Bionic Navigator 3D 4 Installer Freelink Remote Control WaveWriter Alpha IPG Kit CoverEdge MRI 4x8 Surgical Lead Kit WaveWriter Alpha ETS Trial Belt Freelink Remote Control Kit WaveWriter Alpha Prime IPG Kit WaveWriter Alpha 16 IPG Kit WaveWriter Alpha Patient Trial Kit Bionic Navigator Installer WaveWriter Alpha Prime 16 IPG Kit Bionic Navigator 3D 4.1 Installer mySCS GO Therapy Controller Clinician Kit mySCS GO Therapy Controller App Infinion Pro Lead Kit mySCS GO Therapy Controller Patient Kit mySCS GO Therapy Controller App Patient Literature Kit Ranger Paclitaxel-Coated PTA Balloon Catheter Bulkamid Urethral Bulking System ACUITY Spiral Bi Directional Torque Wrench INOGEN CRT-D DYNAGEN CRT-D INOGEN X4 CRT-D DYNAGEN X4 CRT-D ACUITY X4 Spiral CONTAK RENEWAL AVT Software CONTAK RENEWAL Software Application ACUITY X4 Straight ACUITY X4 Flushing Tool/Wire Guide CONTAK CD Software Application VIGILIANT X4 CRT-D VIGILIANT CRT-D AUTOGEN X4 CRT-D MOMENTUM X4 CRT-D RESONATE X4 CRT-D MOMENTUM CRT-D RESONATE HF CRT-D RESONATE CRT-D CONTAK CD2 Software Application AUTOGEN CRT-D ENERGEN CRT-D INCEPTA CRT-D Lead Cap EASYTRAK 3 EASYTRAK 3 IS-1 PUNCTUA CRT-D EASYTRAK 2 IS-1 EASYTRAK 2 Magnet Lead Stabilizer Kit Anchor Sleeve Lead Tunneler Kit Lead Cap Kit Model 1550 AICD Software Module Mineral Oil Lead Stylet Vein Pick J Shaped Lead Stylet Straight Lead Stylet FINELINE II Sterox FINELINE II EZ Sterox Suture Sleeves Express LD Iliac/Biliary Stent System ENROUTE Transcarotid Stent System Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System AMS 800 with Inhibizone AMS 800 without Inhibizone WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT Endoprosthesis Self-Expanding Stent SMARTFREEZE Cryo-Cable SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Console SMARTFREEZE Inter-Connection Box SMARTFREEZE Cryo-Console Foot Switch POLARx Cryoablation Balloon Catheter SMARTFREEZE Remote Control POLARx FIT Cryoablation Balloon Catheter SMARTFREEZE Diaphragm Movement Sensor FLEXTEND Fixation Tool Electrophysiology Cable Sterile Cable Maestro 4000 Controller, RF Cardiac Ablation Controller Blazer Prime HTD Temperature Ablation Catheter Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W IntellaNav ST Ablation Catheter Blazer II HTD Temperature Ablation Catheter Blazer II Temperature Ablation Catheter Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable Maestro Remote Control Cable Non-Sterile Cable (Controller to Pump or Remote Control) LATITUDE Clarity myLUX LUX-Dx Axonics Rechargeable Sacral Neuromodulation System Axonics SNM Therapy Foramen Finder Axonics SNM System Axonics Sacral Neuromodulation System Axonics r-SNM System Axonics System Axonics Axonics Therapy for Bowel Control Axonics Therapy Axonics Sacral Neuromodulation Therapy Colpassist Vaginal Positioning Device FARASTAR IEC Recording System Module ECG Output Module FARASTAR Stimulation Module Male Cable FARASTAR IEC Recording System Module ECG Trunk Cable FARASTAR AAMI Recoding System Module ECG Output Module FARASTAR AAMI Snap Cable R/L FARASTAR Recording System Module FARASTAR Catheter Connection Cable FARASTAR IEC Snap Cable C Set FARAWAVE Pulsed Field Ablation Catheter FARASTAR Mapping System Module FARASTAR Stimulation Module Cable FARASTAR Stimulation Module Y-Cable Short FARASTAR Stimulation Module Y-Cable Long FARASTAR Cable Set FARAWAVE Nav Pulsed Field Ablation Catheter FARASTAR Mapping System Module BNC-Phono Cable FARASTAR EGM Cable FARASTAR Mapping System Module Back Patch Cable Male FARASTAR Gen 2 Catheter Connection Cable FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx FARASTAR Stimulation Module Female Cable FARASTAR Inter-Connection Box FARASTAR EGM to EP Recording System Cable (FARAPOINT) FARASTAR Mapping System Module Auxiliary Cable FARASTAR AAMI Snap Cable V Set FARASTAR Mapping System Module Back Patch Cable FARASTAR Pulsed Field Ablation Generator FARASTAR IEC Snap Cable R/L FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx FARASTAR AAMI Recording System Module ECG Trunk Cable FARASTAR Recording System Module EGM Input Module FARASTAR Recording System Module Catheter Pin Cable FARAPOINT Pulsed Field Ablation Catheter FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx DYNAGEN MINI INOGEN EL DYNAGEN EL VIGILIANT EL ICD INOGEN MINI PERCIVA HF ICD AUTOGEN EL PERCIVA ICD RESONATE HF ICD MOMENTUM EL ICD RESONATE EL ICD PUNCTUA INCEPTA ENERGEN Ureteral Stent Positioners FORMIO VITALIO ESSENTIO ACCOLADE PROPONENT ALTRUA 2 Screw Cap Wrench ALTRUA 60 INGENIO ALTRUA 40 ADVANTIO ALTRUA 20 VENOUS WALLSTENT Self-Expanding Stent ELUVIA Drug-Eluting Vascular Stent System INTUA VALITUDE VALITUDE X4 VISIONIST X4 VISIONIST INVIVE CONTAK RENEWAL TR Software Application Flexima Nephrostomy Catheter System Kit Flexima Nephrostomy Catheter System TLA Introducer Needle and Sheath Set Percutaneous Access Needle Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit Malecot Nephrostomy Catheter Set Flexima Nephrostomy Catheter System Kit with Dissolving Tip Flexima Nephrostomy Catheter System with Dissolving Tip JINRO Pigtail Nephrostomy Catheter Kit Percuflex Locking Loop Nephrostomy Catheter with Fader Tip Re-entry Malecot Nephrostomy Catheter Set Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Percutaneous Access Needle with Echogenic Tip JINRO Pigtail Nephrostomy Catheter Placement Kit JINRO Pigtail Nephrostomy Catheter Percuflex Locking Loop Nephrostomy Catheter VTC Nephrostomy Catheters System Kit VTC Nephrostomy Catheters System Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit Percutaneous Access Set NaviGuide Percutaneous Access Needle Vercise DBS Controller Clinician Kit Vercise Physician's Spare Kit 8 Contact Extension Kit Vercise M8 Adapter Vercise Remote Control Vercise External Trial Stimulator Base Station Charger Vercise Implantable Pulse Generator Kit Vercise Remote Control Kit Bionic Navigator 24 Installer Patient Travel Case Remote Control Case Adhesive Kit IR Interface ETS battery Vercise Charger Collar SureTek Burr Hole Cover Kit Lead Kit Vercise Charging System Vercise DBS External Trial Stimulator 2 IR Interface Holder Vercise Charger Collar Accessories Vercise PC Implantable Pulse Generator Kit AC/DC Power Supply Vercise Neural Navigator 2.1 Installer OR Cable 2x8, 61cm and Extension Precision Spectra IPG Port Plug SP3 Platform Update Installer Vercise DBS Remote Control 3 Vercise Gevia Implantable Pulse Generator Kit Vercise ETS Vercise DBS Remote Control 3 Kit Vercise DBS Directional Lead Kit Vercise Genus Implantable Pulse Generator Kits Vercise Neural Navigator 4 Installer Vercise DBS Remote Control 4 and Kit Vercise Neural Navigator 3.1 Installer Vercise ETS 3 Charger Belt and accessories Vercise Charging System with Belt Push Button OR Cable 2x8 Contact Lead Extension Kit Vercise Charger Vercise Neural Navigator 5 Vercise S8 Adapter Vercise ETS Adapter Vercise Physician's Spare Kit, 16 Contact Lead Vercise DBS Controller Vercise Cartesia HX Directional Lead Kit Lead Extension Kit, 16 Contact Vercise Cartesia X Directional Lead Kit Vercise DBS Controller Patient Kit Vercise Cartesia Directional Lead Kit TheraSphereY-90 Glass Microspheres ENDOTAK RELIANCE G Connector Tools Lead Repair Kit Lead Pulling Tip RELIANCE 4-FRONT Defibrillation Lead Suture Sleeve Accessory Lead Stylets Lead Adapter ENDOTAK RELIANCE ENDOTAK RELIANCE SG ENDOTAK RELIANCE S Innova Vascular Self-Expanding Stent System Connector Ureteral Catheter Connector Connector Drainage Bag Connector Connecting Tube REBEL Platinum Chromium Coronary Stent System ACUITY STEERABLE RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Rotaglide Lubricant Rotablator Dynaglide Foot Pedal wireClip Torquer ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device ROTAPRO Advancer Burr Advancing Device ROTAPRO Rotational Atherectomy System Console Kit ROTAWIRE Drive and wireClip Torquer Floppy RotaWire and wireClip Torquer Extra Support RotaLink Advancer Catheter Advancing Device RotaWire and wireClip Torquer Floppy Rotablator Rotational Atherectomy System Console Kit RotaLink Burr Exchangeable Burr Catheter ROTAWIRE Drive and wireClip Torquer Extra Support AC Power Cord LATITUDE NXT Server Software Software Disk for the VENTAK MINI Pulse Generators LATITUDE Consult Communicator LATITUDE G2 Communicator LATITUDE Communicator Power Supply LATITUDE Programming System LATITUDE Patient Management System LATITUDE WAVE Communicator BATTERY Accessory kit For use with the Model 3120 Programmer Recorder Monitor PRM Multiple Application Utility (MAU) USB Cable DF-1/3.2-mm Lead Port LATITUDE Communicator RF LATITUDE Consult System Power Cord LATITUDE NXT LATITUDE Communicator Software Disk for the VENTAK PRx Pulse Generators LATITUDE Power Supply Software Disk for the VENTAK PRx II / III Pulse Generators LATITUDE Communicator Inductive Antenna LATITUDE Consult System Software STERILZABLE TELEMETRY WAND LATITUDE Consult Power Supply LATITUDE Communicator with Wand LATITUDE Server Software Telemetry Wand Power Adapter Model 6942 Bidirectional Torque Wrench ZOOM Wireless Transmitter ZOOM LATITUDE Programmer/Recorder/Monitor Axonics Therapy for Urinary Control Cable, Maestro 4000 Blazer Open-Irrigated Ablation Catheter MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set MetriQ Foot Switch MetriQ Pump Irrigation Pump IntellaNav Open-Irrigated Ablation Catheter IntellaTip MiFi Open-Irrigated Ablation Catheter IntellaNav MiFi Open-Irrigated Ablation Catheter Rhythmia HDx Ablation Connection Box Maestro RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 10 Meter IntellaNav StablePoint Catheter Cable Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set Cable IntellaTip MiFi OI to Maestro 4000 IntellaNav StablePoint Ablation Catheter Cable, IntellaTip MiFi OI INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN Irrigation Pump Connection Cable 5 Meter Stone Cone Nitinol Urological Retrieval Coil WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System Wrench Kit

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only