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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Family of Implantable Pulse Generators

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ADAPTER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Extensions

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

FDA Pre-Market Approval

FDA Class 3 ·QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL UJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS

FDA 510(k)

FDA Class 3 ·Cardiovascular

STERILIZATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR PERMANENT PACING LEAD RZ MODEL SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular