Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone Treatment

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 ·SENSOLOG (R) MODEL 3038 SOFTWARE MODIFICATION

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICAL URINARY SPHINCTER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS Sphincter 800 Urinary Control System

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 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) THERA(TM) PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·RELAY

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Tendril MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DEMA/DIVA IMPLANTABLE PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Endurity, Endurity Core, and Assurity pacemakers

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)