Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PRIMA PLUS STENTLESS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS; RSR, THEON RSR WITH

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PORCINE AORTIC BIOPROTHESIS AND PORCINE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE, MODELS 2700 AND 2800

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHETIC HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM