Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON...

Replacement Heart-Valve

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PERIMOUNT, RSR, THEON, RSR PERICARDIAL AORTIC BIOPROSTHESES & VARIOUS FAMILIES OF MAGNA, THEON, PLUS

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 ·PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK VALVED CONDUIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI 4965/4968

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINELINE/FINELINE II ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE AND CAPSURE NOVUS FAMILIES OF LEADS/ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Perimount Aortic and Mitral Bioprostheses

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX ENDOCARDIAL 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 ·CARPENTIER-EDWARDS BIOPROSTHESIS MODELS 2625,6625, VALVED CONDUIT MODEL 4300