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

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE AND AORTIC VALVE GRAFT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (MR)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV/VR/PRIZM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Model 3028 IPG

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST and VALITUDE

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

FDA Pre-Market Approval

FDA Class 3 ·SelectSecure Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Altrua 2, Essentio, Proponent, and Accolade Non-MRI Pacemakers

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Surmodics SurVeil™ Drug-Coated Balloon