Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FR3 Defibrillator

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO ABLATION, THERAPY COOL PATH SP ABLATION CATHETER,SAFIRE BLU DUO ABLATION CATHETER,SAFIRE BLU DUO S

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS EON,EONC,EON MINI,PROTEGE,PROTEGE MRI,AND PROCLAIM FAMILY SPINAL CORD STIMULATION (SCS) SYSTEMS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE CARDIAC ABLATION SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·BRIO FAMILY DEEP BRAIN STIMULATION (DBS) SYSTEMS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

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

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY CARDIAC ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP