Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+ C & T SERIES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Coronary Stent System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacemaker System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity Coronary Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·Venaseal Closure System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Talent Occluder With Occluder Delivery System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Isoflex Low Voltage Lead

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE, RADIESSE LOW VISCOSITY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE LOW VISCOSITY, RADIESSE (+)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Isoflex Low Voltage Leads

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE BIOPROSTHESIS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex Low Voltage Passive

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING

Replacement Heart-Valve

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE