Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APS-II MODEL 3003 PROGRAMMER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ELITE II MODEL 7086

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY, SOLUS, PHOENIX, PARAGON AND TRILOGY FAMILY OF PULSE GENERATORS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS SUPRA-ANNULAR (S.A.V.) BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA RATE-RESPONSIVE PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TEMPO DR 2102 AND TEMP D 2902

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX

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 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/ Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS+ FAMILY OF PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ALIZEA and CELEA pacemakers, Remote monitoring software (RMS)