Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·C-SERIES AND T-SERIES DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·META AND TEMPO PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACEMAKER SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PACEMAKER SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF SLX LEADS AND VARIOUS MODELS OF SELOX,DEXTRUS,AND SAFIO DRUG ELUTING LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICD DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SIGMA PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead/CapSure SP Novus Lead/CapSureSense Lead/Vitatron Crystalline Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DIVA PLATFORM IMPLANTABLE PULSE GENERATORS & PRO VIT APPLICATION SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SETROX S 45, SETROX S 53, SETROX S 60, DEXTRUS 4135, DEXTRUS 4136, DEXTRUS 4137, SAFIO S 53, SAFIO S 60, TILDA JT45, TIL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY ICD'S