Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNERGYST II PULSE GENERATOR SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity, Assurity, and Accent

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM1152, PM2152

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW hotspot

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DEMA/DIVA IMPLANTABLE PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Home Monitoring System Version 3.56.0

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Mnagement System

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY(R) CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ADDITION OF ALTERNATE TUBING EXTRUDER