Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKO EGFR PHARMDX KIT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·VIBRANT SOUNDBRIDGE SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

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 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORETEC HEARTMATE XVE LVAS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM CGM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)