Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF MONFOCAL/ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES/ACRYSERT DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Tupos LV/ATx and Kronos LV-T CRT-D System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, and Intica Neo 5 DR-T

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, and Intica Neo 5

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·BALLOON CATHETER

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Element Plus Everolimus-Eluting Coronary Stent System, Promus PREMIER Everolimus-Eluting Coronary Stent System, P

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Dromos DR/SR Rate Adaptive Pacing Systems