Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implatable, with Cardiac Resynchronization (CRT-P), Drug Eluting Permanent Left Ventricular

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Rotlex IOLA MFD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATRO LEAD,SUBCUTANEOUS LEAD

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva SCI

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval

FDA Class 3 ·LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Packing Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Performa Lead and Attain Stability Quad MRI Lead

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve, Medtronic Evolut™ PRO+ Transcatheter Aortic Valve, Medtroni

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIPLOS MODEL 03

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION PUMPS/INTRA-ARTERIAL VASCULAR CATHETERS/VASCULAR CATHETERS/INDURA 1P INTRATHECAL CATH

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO,IFORIA,LUMAX

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD AND ATTAIN OTW LEAD