Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled RF Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express SD Monorail Premounted Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (rebrand of PROMUS Element Plus)

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

FDA Pre-Market Approval

FDA Class 3 ·R3TM delta Ceramic Acetabular System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE USP

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC-ONE (HYLAN G-F 20)

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(TM)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA CRTS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX Ceramic Total Hip System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRTD, Cobalt M

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 018