Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC 8040 DEVICES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVISA, ENRHYTHM MRI

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·REVEAL DX, REVEAL XT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR,

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT D, MAXIMO II CRT-D, CONCERTO II CRT -D, CONCERTO CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA XT CRT-D, V

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMDOGAIN GEL

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·RayOne EMV

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE, EVERA S DR ICD, S VR ICD, XT VR DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD XT ICD, RV LEAD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF MARINR MC (7FR), RF MARINR 5FR, RF CONTACTR, RF CONDUCTR, RF ENHANCR II,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR , S VR XT DR , XT VR . MAXIMO II , PROTECTA, XT ICD, RV, SECURA, VIRTUOSO II DR/VR ICDS/

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Dissection Endovascular System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCHECK PATIENT ASSISTANCE, TRANSVENE CS/SVC LEAD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, CARELINK, ENCORE AND REVEAL PROGRAMMER, MONITOR READER & SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX LEAD, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS