ABBOTT MEDICAL

DS2C022, DS2C023, DS2C024, DS2C025, DS2C026, DS2C027, DS2C028,DS2C029, DS2C030 CPS Direct Universal Slittable Outer Catheter, Models DS2C018, DS2C019, DS2C020, DS2C021 Zenex MRI PM1283 St Jude Medical MR Conditional Pacemaker System Zenex MRI PM2283 Anthem Relieve Quadra MitraClip™ G5 Steerable Guide Catheter CPS Direct PL CPS Direct PL VBT Renal Guide Catheter MitraClip Steerable Guide Catheter TriClip™ G5 Steerable Guide Catheter MitraClip G4 Steerable Guide Catheter TriClip Steerable Guide Catheter CPS Direct Mediguide Enabled Outer Catheter Models - DS2M021, DS2M022, DS2M023 Confirm Rx ICM Accessory Kit Suture Sleeve Accessory DS2A088 Tendril SDX, Tendril ST, Tendril STS, OptiSense, Tendril DX Leads UltiPace Bradycardia Pacing Lead Model LPA1231 myCardioMEMS Patient Application for the CardioMEMS HF System Merlin.net web application Merlin.net web database Merlin Data System Merlin.net Web Application and Database CPS Direct Universal Slittable Outer Guide Catheter (Redesign) (DS2C029) Magnet, model 3111 Merlin Patient Care System Software Model 3330 Version 18.1.1 Quadra Allure MP Frontier, Frontier II, Anthem Family of CRT-PS Confirm Rx Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40 CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030 IS-1/Quadripolar Terminal Cap Aveir Retrieval Catheter - Model LSCR111 SJM Confirm Implantable Cardiac Monitor, Model DM2100 Merlin.net VDE MN7000 with AI Stylet Models 4060, 4062, 4064. 4090, 4091, 4078 SJM Confirm ICM Model DRM2100, SJM Confirm PA Model DM2100A PSA Cables and Adapters CPS AIM™ Universal II Slittable Inner Catheter DS2N100-59, DS2N100-65, DS2N101-59, DS2N101-65, DS2N102-59, DS2N102-65, DS2N103-65, DS2N104-65 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 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 myMerlin™ Mobile Application, Model APP1001 Nanostim Introducer Kit Endurity family of pacemakers Fortify ST and Fortify Assura ST AnalyST Accel Fortify Assura Ellipse and Ellipse ST Fortify Confirm Implantable Cardiac Monitor and Patient Activator SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR CPS Excel MediGuide Guidewire CPS Excel MediGuide Enabled Guidewire Models - DS2M031, DS2M032 SJM Confirm Implantable Cardiac Monitor (MR Conditional) Agilis HisPro Steerable Catheter With Electrodes Model DS3H010-38 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 CPS Aim MediGuide Enabled Inner Catheter Models - DS2M051, DS2M052, DS2M053, DS2M054, DS2M055 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, 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 Aveir Introducer models LSN25301, LSN25501 CPS Direct MediGuide Enabled Outer Catheter Models - DS2M041, DS2M042, DS2M043, DS2M044 Regency family of pacemakers Endurity MRI and Assurity MRI families of pacemakers ACCENT ST MRI Endurity Core Accent MRI Jot Dx Insertable Cardiac Monitor CardioMEMS™ HF System CardioMEMS™ Hospital Electronics System CardioMEMS™ Patient Electronics System Merlin.net™ Patient Care Network Heart Failure Portal CardioMEMS™ PA Sensor and Delivery System CardioMEMS™ Hospital System CardioMEMS™ HERO Device Merlin PSA Patient Cable EX 3150, Cable Adapter EX3170, "M" Adapter EX3180 Assert-IQ™ 3, 3+, EL, Insertion and Incision Tools - Models DM5000, DM5300, DM5500, DM5310, DM5510, DM5320 Adapting sleeve kit model 4023 Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads CPS Aim SL Slittable Inner Catheter Models DS2N021-59, DS2N021-65, DS2N022-59, DS2N022-65, DS2N023-59, DS2N023-65, DS2N024-65, DS2N025-65 Optisure High Voltage Lead Family Durata, Durata DF4 Transvenous Defibrillation Leads CPS Direct SL II Slittable Outer Catheter Models - DS2C007, DS2C017 CPS 4F Slitter Model DS2A000, CPS Valve Bypass Tool (Aim SL) Model DS2A002 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 SJM Confirm Implantable Cardiac Monitor (ICM), Model DM2102 Pulse-generator, single chamber CPS Direct SL Outer Catheter-410190 Current DR, VR ICD, Merlin Antenna, Promote ICD Vein Pick Neutrino NxT Models - CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA800T, CDVRA600T, CDDRA800T, CDDRA600T Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR Merlin Patient Care System Software Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Merlin.net Patient Care Network s/w Silicone Oil DF-1 Receptacle Plug, Hex Wrench, Entrant Models - CDDRA300Q, CDVRA300T, CDDRA300T Merlin Live Connect Software Model MLC1000 Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T Gallant Models - CDVRA500Q, CDDRA500Q, CDVRA500T, CDDRA500T Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR Stylet Kit, Promote ICD Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD IS-1 Receptacle Plus, Medical Adhesive Merlin@home Transmitter software, Durata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4 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 Mond RVOT Stylet Bluetooth USB Dongle Model BLU2000 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 Unify Unify Quadra MP Excelis Plus Quadra Quadra +Excelis Quadra Assura Excelis Quadra Unify Assura Quadra Assura MP Unify Quadra

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only Sterilize Medical Device for Another Party (Contract Sterilizer)