Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MODELS 4004/4504 PACING LEADS

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 ·HANCOCK PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per

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 ·Hancock II Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)

Replacement Heart-Valve

FDA Pre-Market Approval

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myopore Sutureless Myocardial Pacing Lead

Replacement Heart-Valve

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) SCREW-IN STEROID ELUTING LEAD

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHETIC VALVED CONDUIT AND HANCOCK TROCAR BLADES AND HANDLE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SELUTE LEADS AND ACCESSORIES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MYOCARDIAL PACING LEAD

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROTHESIS MODELS T505, T510

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650