Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECH CORE

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·Esteem® Totally Implantable Hearing System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·INTENSIA VR 124, INTENSIA DR 154, INTENSIA CRT-D 174

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON B SOFT CONTACT LENSES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·SECURE -C CERVICAL ARTIFICIAL DISC

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Lap-Band System

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA System

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·PEARL 8.0 HANDPIECE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK MONITOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC OPEN PIVOT HEART VALVE

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER,CRIBRIFORM OCLUDER,AND DELIVERY AND EXCHANGE SYSTEMS

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·C2A-TAPER ACETABULAR HIP SYSTEM