Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Porcine Bioprosthesis

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP PACING LEADS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Low Porosity Valved Conduit

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS