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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

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 ·COGNIS PULSE GENERATORS - MODELS N118 & N119

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS Bowel Accessories SNS Bowel Extensions SNS Bowel LeadsSNS Bowel Neurostimulators SNS Bowel Programming SNS Bowel Scr

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI & Quad CRT-D's; Brava CRT-D & Quad CRT-D's; Compia MRI CRT-D & Quad CRT-D; Viva Quad S & XT CRT-D; Viva S CR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD, LINOX SMART S, VOLTA 1CR, VOLTA 2CR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR PACINGS LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR DEFIBRILLATION LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS