Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·BIOBURDEN TESTING

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP;PARADIGM REAL-TIME REVEL INSULIN PUMP

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·UNIFY CRT-D SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX, OptiSense, Tendril STS, Tendril ST

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INTUITY Elite Valve System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL STS 1988TC AND 2088TC

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·INDENTITY & IDENTITY ADX FAMILY OF DEVICES

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK, RX

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva Genesys HTA Endometrial Ablation System