Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625

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 PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AORTIC BIOPROSTHESIS, RSR PERICARDIAL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES

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 ·Mosaic Bioprosthesis, Mosaic Ultra Bioprosthesis

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora, Evity, Enitra, Enticos 8SR/ SR-T/ DR/ DR-T

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SIGMA MODELS SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 AND SVDD303

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS PROCINE BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Accent MRI Pacemaker

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·POLY-SAFE(TM) A-TRACK(TM) PACING LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE