Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ST.JUDE MEDICAL ICDS/CRT-D

Implantable Pacemaker Pulse-Generator

FDA classification

FDA Class 3 ·Implantable Pacemaker Pulse-Generator

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM