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

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

PELLETHANE 75D

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

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

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

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

HT, MODEL HT PB

FDA 510(k)

FDA Class 3 ·Cardiovascular

LOCATOR MODEL 4036

FDA 510(k)

FDA Class 3 ·Cardiovascular

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

FDA 510(k)

FDA Class 3 ·Cardiovascular