Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM,RETROFLEX BALLOON CATHETER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3