ABBOTT MEDICAL

Optisure High Voltage Lead Family Durata, Durata DF4 Transvenous Defibrillation Leads Pacel Bipolar Pacing Catheter 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 Pulse-generator, single chamber Quadra Assura CRT-D, Unify Assura CRT-D Promote CRT-Ds, Stylet Kit, Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick Current DR, VR ICDs, Promote ICDs, Merlin Antenna QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve, Merlin Patient Care System Software Model 3330 Version 18.1.1 CRT Leads, Quickflex Left Heart Leads Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System CPS Direct PL Peelable Outer Guide Catheter, Accessory Valve Bypass Tools 410170, 410171, 410172, 410173, 410174, 410175, 410176, 410177, 410180, 410181, 410182, 410183, 410184, 410185 410220, 410221, 410222, 410223, 410225, 410193, 410194 410186, 410187, 410210, 410211, 410212, 410213, 410214, 410215, 410216, 410224, 410217, 410218, 410219 DS2C022, DS2C023, DS2C024, DS2C025, DS2C026, DS2C027, DS2C028,DS2C029, DS2C030 CPS Direct Universal Slittable Outer Catheter, Models DS2C018, DS2C019, DS2C020, DS2C021 ECG Adapter Pacel Flow Directed Pacing Catheter Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764 Agilis HisPro Steerable Catheter With Electrodes Model DS3H010-38 CPS AIM™ Universal II Slittable Inner Catheter DS2N100-59, DS2N100-65, DS2N101-59, DS2N101-65, DS2N102-59, DS2N102-65, DS2N103-65, DS2N104-65 Aveir Link Module - Model LSL02 Aveir Delivery Catheter - Models LSCD201, LSCD111 Aveir Leadless Pacemaker - Models LSP112V, LSP201A, LSP202V Aveir Patient Transmitter Software - Model LSRM1000 Aveir Patient Transmitter - Model LSRM01 Aveir Patient Transmitter Wired Electrodes - Model LSRMC01 AVEIR AR 2 Leadless Pacemaker - Model LSP203A CPS Slitter, Model DS2A003 Agilis HisPro Slitter, Model DS3A001 Helix Locking Tool (HLT), Model A001HELX CPS Universal II Slitter, Model DS2A006 CPS 3D Plus Slitter, Model DS4A001 Pacel™ Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773 Aveir Retrieval Catheter - Model LSCR111 Zenex MRI PM1283 St Jude Medical MR Conditional Pacemaker System Zenex MRI PM2283 SJM Threshold Cable SJM Patient Cable Pacel Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable, Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR; Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers Accent; Sustain XL SC, DC, SR, DR; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR CPS Direct SL II Slittable Outer Catheter Models - DS2C007, DS2C017 CPS Direct MediGuide Enabled Outer Catheter Models - DS2M041, DS2M042, DS2M043, DS2M044 Suture Sleeve Accessory DS2A088 Tendril SDX, Tendril ST, Tendril STS, OptiSense, Tendril DX Leads UltiPace Bradycardia Pacing Lead Model LPA1231 CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030 CPS Aim Universal Slittable Inner Catheter, Models DS2N026-59, DS2N027-59, DS2N028-59, DS2N026-65, DS2N027-65 CPS Aim Universal Slittable Inner Catheter, Models DS2N028-65, DS2N029-65, DS2N030-65 CPS Aim SL Slittable Inner Catheter Models DS2N021-59, DS2N021-65, DS2N022-59, DS2N022-65, DS2N023-59, DS2N023-65, DS2N024-65, DS2N025-65 Quadra Allure MP Frontier, Frontier II, Anthem Family of CRT-PS CPS Direct Mediguide Enabled Outer Catheter Models - DS2M021, DS2M022, DS2M023 Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads CPS 4F Slitter Model DS2A000, CPS Valve Bypass Tool (Aim SL) Model DS2A002 CPS Excel MediGuide Guidewire CPS Excel MediGuide Enabled Guidewire Models - DS2M031, DS2M032 CPS Aim MediGuide Enabled Inner Catheter Models - DS2M051, DS2M052, DS2M053, DS2M054, DS2M055 CPS Direct SL II Slittable Outer Catheter DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, DS2C006, DS2C011, DS2C012, DS2C013, DS2C014, DS2C015 CPS Universal II Slitter Model DS2A004 CPS Universal Slitter Model DS2A003 Aveir Introducer models LSN25301, LSN25501

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only