Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI SureScan Lead Model 5086MRI

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus MRI SureScan Lead Models 4076 and 5076

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters

Separator, Automated, Blood Cell And Plasma, Therapeutic

FDA Pre-Market Approval

FDA Unclassified ·COBE CENTRY(R) TPE SYSTEM

Separator, Automated, Blood Cell And Plasma, Therapeutic

FDA Pre-Market Approval

FDA Unclassified ·COBE CENTRY(R) TPE SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CT & 2 CR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR/2CT DEFIBRILLATION LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX & CRYSTALLINE ACT FIX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR AND ISOLINE 2CT LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR, ISOLINE 2CT STEROID ELUTING PACING LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7