Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO & TRANSVENE CS/SVC LEADS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 Drug Coated Balloon PTA Catheter

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 ·SelectSecure Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODELS 925, 2040, 2041, 6564

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MODELS 8416 AND 8418 LEGEND PACEMAKERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI SURESCAN LEAD 5086MRI

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY/THERA I IPG

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM