Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9855 SOFTWARE 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 ·APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACING LEADS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS SPHINCTER 800 URINARY PROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR+ -B PULSE GENERATOR

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI

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 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI Pacemakers and Endurity MRI Pacemakers

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META MV MODEL 1202 CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VDD STEROID-ELUTING LEAD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H

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 ·ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)