Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pulsar, Pulsar Max, Discovery, Nexus, Intelis, Insignia, Altrua, Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·7F FREEZOR CARDIAC CRYOABLATION CATH.& XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic Plus, Epic Plus Supra and Epic Max Valves in the Epic Valve Sterilization Process

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT ADVANCE CARDIAC CRYOBL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOBLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC CR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor, Freezor Xtra and Freezor MAX Cardiac Cryoablation Catheter, Electrical Umbilical and Coax Umbilical cable

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS & CCT. CRYOCONSOLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Catheter, Freezor Xtra Catheter, Freezor MAX Surgical Device, Electrical umbilical cable, Coaxial umbilical cabl

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTRA & MAX SURGICAL CRYOABLATION & CCT.2 CRYOCONSOLE SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510

Replacement Heart-Valve

FDA Pre-Market Approval

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·7F FREEZOR CARDIAC CRYOABLATION CATHETER & XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, 9F FREEZOR MAX SURGICAL CARDIAC

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla