Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING,CARPENTIER-EDWARDS DURAFLEX LOW

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent Implantable

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY VDR MODEL 5430 PULSE GENERATOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S

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 ·SYNCHRONY(R) CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Carpentier-Edwards Perimount Theon Percardial Aortic Biop

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Setrox S, Solia S, Safio S

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS