Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META MV MODEL 1202 & 1202 PULSE GENERATORS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS MEDICAL HEART VALVE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GELSYN-3

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL (TM)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REFLEX MODEL 8223E DUAL CHAMBER PULSE GENERATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL (TM)

Programmer, Pacemaker

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEX MODEL 8220E SINGLE CHAMBER PULSE GENERATOR

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·V1. 2A PROGRAMMER SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META III MODEL 1206,1206E,1206M PACING SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·REGENCY SC+, REGENCY SC, REGENCY SCX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON, PHOENIX, MULTILOG & SENSORITHM PACEMAKERS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·N.C.G.T. GRAFT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS