ABBOTT VASCULAR

XIENCE V Everolimus Eluting Coronar Xience V Xience Nano XIENCE V, RX Drug Eluting Stent System XIENCE V, OTW Drug Eluting Stent System Armada 14 NC PTA Catheter Pacel Bipolar Pacing Catheter Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764 RX Herculink Elite Renal Stent System HT SPARTACORE HT STEELCORE HT SUPRA CORE Hi-Torque BMW Elite Guide Wire Hi-Torque VersaTurn Flex Guide Wire Hi-Torque VersaTurn Ultraflex Guide Wire Hi-Torque VersaTurn Guide Wire JETi Hydrodynamic Thrombectomy System Ultra RX Armada 14 PTA Catheter X.act Carotid Stent System Xact Carotid Stent System XACT Transcarotid Stent System Mini Trek OTW Mini Trek RX Mini Trek II OTW PressureWire X HT Command 14 ST HT Command 14 MT RX Herculink Elite Biliary Stent Sy Ultiri Measurement System Rotating Hemostatic Valve Hi-Torque Wiggle Guide Wire DOC Guide Wire Extension ILUMIEN System ILUMIEN Guided Therapy System ILUMIEN Therapy Guidance System Hi-Torque Steelcore Guide Wire Hi-Torque Steelcore 18 Guide Wire Dragonfly OpStar™ Imaging Catheter. ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2 ILUMIEN Systems with AptiVue Software Version D.3 E.4 Metallis Stent Optimization E.4 SW NC TREK RX Coronary Dilatation Catheter Rotating Hemostatic Valve (.115) NC TREK OTW CORONARY DILATATION CATHETER Hi-Torque BMW Universal II Guide Wire Hi-Torque BMW Universal II Hi-Torque Traverse Guide Wire Hi-Torque Supra Core Guide Wire ILUMIEN OPTIS System and Accessories PPAK 20/30 w/.115 RHV 20/30 Indeflator 20/30 PPAK with Bleedback Control Valve PPAK 20/30 w/96 RHV RX Viatrac 14 Plus Peripheral Dilat RX Viatrac 14 Plus Peripheral Pacel™ Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773 Viatrac 14 Plus CoroFlow Cardiovascular System Omnilink Elite TAD II Guide Wire TAD Guide Wire Barewire Filter Delivery Wire Emboshield NAV6 Embolic Protection System JETi Non-sterile Canister Set StarClose SE Vascular Closure System Omnilink 35 Biliary Stent System Hi-Torque Powerturn Guide Wires Armada14 XT Dilatation Catheter Armada 18 PTA Catheter Supera OPTIS Mobile Next Imaging System Ultreon 3 Software Upgrade Kit OPTIS Integrated Next Imaging System Hi-Torque JET Guide Wire Flexi-Wire Hi-Torque Extra S'port Hi-Torque Whisper Guide Wires HI-TORQUE CROSS-IT 400XT GUIDE WIRE Trek RX Trek OTW Mini Trek II OTW (1.20 LTD IND Mini Trek OTW Dilatation Catheters Mini Trek II OTW (1.50-20) LOC Guidewire Extension Hi-Torque Versacore Standard Guide Wire Hi-Torque Versacore Floppy Guide Wire Hi-Torque Versacore Modified J Guide Wire Hi-Torque Versacore Guide Wire ILUMIEN OPTIS Mobile System ILUMIEN OPTIS Mobile System Accessories NC TREK NEO ProGlide Perclose AT Prostar XL 10 F Perclose ProStyle Suture-Mediated Closue and Repair System ECG Adapter Pacel Flow Directed Pacing Catheter Absolute Pro Vascular Self-Expanding Stent System Absolute Pro Self-Expanding Stent System Hi-Torque Balance Guide Wire Hi-Torque Pilot Guide Wire Hi-Torque Progress Guide Wire OPTIS Mobile System and Accessories Hi-Torque Balance Trek Guide Wire Hi-Torque Balance Middleweight Elite Guide Wire H-Torque Balance Middleweight Guide Wire Hi-Torque Balance Middleweight Universal Guide Wire Hi-Torque Balance HeavyWeight Guide Wire Hi-Torque Balance Meddleweight Universal II Guide Wire Hi-Torque Proceed Guide Wire HI-TORQUE Steelcore Bare Guide Wire Torque Device PTA 25-38 Torque Device (10 Pack) Guide Wire Accessory Kit with RHV Guide Wire Introducer Guide Wire Accessory Kit Torque Device; Guide Wire Introducer; Guide Wire Accessory Kit; Guide Wire Accessory Kit with RHV Accessory Kit with Bleedback Control Valve Torque Device OPTIS Mobile Next Optis Tableside Controller Next Optis Integrated Next Optis Mobile Next Imaging System Optis Integrated Pre-Install Kit Optis Mobile Next Direct Upgrade Accessory Kit Optis Next Upgrade Kit Ultreon 2 Software Upgrade Kit Hi-Torque Infiltrac Guide Wire Absolute Pro LL Self-Expanding Stent System ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter Dragonfly OPTIS Imaging Catheter Kit Hi-Torque Command 18 Disposable Patient Cables SJM Adapter Cable Connectors SJM™ Patient Cable 401758,401759,401760 SJM™ Threshold Cable 401748 SJM™ Epicardial Cable 401777, 401778 Abbott Medical Threshold Cable Abbott Medical Epicardial Cable Abbott Medical Patient Cable Hi-Torque Floppy II Guide Wire XPERT PRO Hi-Torque Floppy 18 OPTIS Integrated System and Accessories Armada 35 and 35LL Dilatation Catheters JETi Accessory Cart Hi-Torque Floppy II Extra Support Hi-Torque Winn Hi-Torque All Star Guide Wire Hi-Torque Command Guide Wire Absolute Pro 35 Biliary Self-Expanding Stent System Trek RX; Mini Trek RX (1.50-20 Global); Mini Trek RX (1.20 LTD IND); XIENCE Alpine Everolimus Eluting Stent System XIENCE Xpedition Everolimus Eluting Stent System XIENCE Sierra Everolimus Eluting Stent System XIENCE Skypoint Everolimus Eluting Stent System XIENCE PRIME Everolimus Eluting Stent System XIENCE ProS Everolimus Eluting Stent System Hi-Torque Flex-T Guide Wire Graftmaster Graftmaster RX Dragonfly OPTIS Imaging Catheter Hi-Torque TurnTrac Guide Wires Hi-Torque Extra S'Port Guide Wire Hi-Torque Flexi-Wire Guide Wire Hi-Torque Balance Middleweight Guide Wire Hi-Torque Connect Esprit BTK Everolimus Eluting Resorbable Scaffold System RX ACCULINK CAROTID STENT SYSTEM Hi-Torque Connect Guide Wire Guide Wire Accessory Kit with Copilot 20/30 PPAK w/COPILOT COPILOT BBC Valve Hi-Torque Cross-It XT Hi-Torque Iron Man Spartacore Guide Wire Hi-Torque Iron Man Guide Wire W/Mic ILUMIEN™ OPTIS™ System AptiVue™ Imaging Software version E.6 OPTIS™ Integrated System OPTIS™ Mobile System NC TREK RX CORONARY DILATATION CATHETER Hi-Torque Balance Middleweight Guide Wire with Microglide Coating Hi-Torque Balance Middleweight with Hydrophilic Coating Hi-Torque Floppy II w/ Hydrocoat Hi-Torque Floppy II Extra Support w/ Hydrocoat Multi-Link Mini Vision Multi-Link Vision- MULTI-LINK 8 Stent System Multi-Link 8- Mini Trek II OTW Coronary Dilatation Catheter

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