Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwars PERIMOUNT Pericardial Aortic Bioprosthesis/ ThermaFix tissue process; Carpentier-Edwards PERIMOUNT RSR

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510

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 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward

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 DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS,MODELS 2625 & 6625

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 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP