Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S45, S53, S60 and Solia S45, S53, S60

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity MRI ,Assurity MRI Pacemaker

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY MODEL 2020T CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II,ELITE & LEGEND PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent, Implantable

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·NETWORK PROGRAMMER MODEL 9602

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·POLYSAFE(TM) A-TRACK(TM) MODEL AT-332 ENDOCARDIAL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META-MV,PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity, Assurity, Endurity Core, Zenus, Zenex

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VIGOR DR/SR, DISCOVERY, and MERIDIAN

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC DUAL CHAMBER PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE

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 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CODEL 9600,4810,4510 5603,INTERFACE CABLE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) SAVVI(TM) SERIES 305 VDD PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS