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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix/CapSureFix Novus/Vitatron Crystalline Active Fixation Lead

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/VERSA/SENSIA/RELIA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM Iliac

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Anchoring Sleeve Kit and SelectSecure Lead

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN, AUTOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITA ENHANCR II

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ESOPHAGEAL PACING SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·NOVAFLEX+ DELIVERY SYSTEM, ASCENDRA+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, ASCENDRA+ INTRODUCER SHE