Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Procine Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS, LOW POROSITY VALVED CONDUIT MODEL 105

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 BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS® PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis, Models T505 and T510

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial

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 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES

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 PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Porcine Bioprosthesis