Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ADDVENT/AV PLUS DX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KELVIN (R) PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

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 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reocor S, Reocor D

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC DUAL CHAMBER PACEMAKERS