PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA

FDA 510(k)

FDA Class 3 ·Cardiovascular

APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE

FDA 510(k)

FDA Class 3 ·Cardiovascular

TELECTRONICS SREW-IN/SLIM LINE PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

MODELS 8420 THRU 8423 PACEMAKER GENER

FDA 510(k)

FDA Class 3 ·Cardiovascular

FIRSTSAVE BIPHASIC MODELS 9200 AND 9210

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT™ Endoprosthesis

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS and Micra TPS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion Systems

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL