Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN CONTROL KIT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·3F AORTIC BIOPROSTHESIS, MODEL 1000

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR MRI A2DR01

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX ICDS AND CRT-DS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CERVICAL-STIM CERVICAL FUSION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·THERA/THERA-I

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM