Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD/ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/II ICDS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/SP/Z NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS)

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON LEGACY IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD/SLEEVE KIT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 IPG

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICES (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STEN SYSTEM