Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON SOFTWARE MULTIPLE SOFTWARE MODELS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DIVA PLATFORM,DERMA PLATFORM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·RELAY/DASH/STRIDE & DART PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR MODEL 1256 PULSE GENERATOR

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM (AUS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAIROS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS SPHINCTER 800 URINARY CONTROL SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACING LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent Implantable

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/600, SIGMA AND 350 SERIES FAMILIES OF PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply DR, Esprit SR, Esprit DR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 1704.U

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM