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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and

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

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

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX FAMILY OF LEADS (1944,1948)

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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL AND OPTISENSE FAMILY OF LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV-T

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·BELOS VR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540

OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED OSCOR PY PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)

FDA 510(k)

FDA Class 3 ·Cardiovascular

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX CRT DEVICE & CARDIOMESSENGER II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T AND CYLOS DR-T