Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·AME BONE GROWTH STIMULATOR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epsila EV Extravascular Lead

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CLEARSOFT (METHAFILCON A) SOFT COTACT LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE LEAD

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cervista HPV 16/18 Assay

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Pacing Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS/CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Drug-Eluting Permanent Defibrillator Electrodes

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ASTRON STENT SYSTEM