Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS, Micra VR TPS

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED) and FRED X System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR, PATIENT BOX

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A SOFT HYDROPHILIC SPERICAL/TORIC CONTACT LENSES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM AND SPINAL STIM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE (R) SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SVC/CS TRANSVENE LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENO MRI SURESCAN IPG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-COREK PLUS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60