Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Injectable Gel Implants

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

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

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI Steroid Eluting Cardiac Leads

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ThermoCool SmartTouch SF

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AMO CLARIFLEX INTRAOCULAR LENSES (IOL) ( MODELS CLRFLX/CLRFLXB/CLRFLXC) & TECNIS CL 3-PIECE INTRAOCULAR LENS (IOL)

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Absolute Pro Vascular Self-Expanding Stent System.

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION RX, VISION OTW MINI VISION RX, MINI VISION OTW

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT RSR Theon/Magna/Plus Pericardial Aortic Bioprosthesis with ThermalFix tissue process,

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC10 & PC21

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-P

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM