Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SELECTED FAMILIES OF ICD'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC FAMILIES OF CRT-ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICD'S

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MHY

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System/Allegro Topolyzer Vario

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System/Allegro Topolyzer Vario

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·MLI 1000 ND:YAG OP LASER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System, Endurant II Aorto-Uni-Ilia

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT II AUI STENT GRAFT SYSTEM

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval

FDA Class 3 ·Koning Breast CT, KBCT (Model CBCT1000)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT,ENDURANT II AND ENDURANT II AOTYO-UNI-LIAC (AUI) STENT GRAFT SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device