Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 CRT-D

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, INCEEPTA, ENERGEN, PUNCTUA, TELIGEN , ICD'S

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODELS 925, 2040, 2041, 6564

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMO(R) VITRAX(R) VISCOELASTIC SOLUTION

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADAPTOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN HE

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LASTAC SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM DR/VR AICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD/EASYTRACK CRT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR