Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT, ENDURANT II, ENDURANT II AORTO -UNI-ILIAC (AUI) AND ENDURANT II'S STENT GRAFT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer OI, IntellaNav OI, IntellaTip Mifi OI, and IntellaNav Mifi OI Cardiac Ablation Percutaneous Catheter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO,ENTRUST,MAXIMO,INTRINSIC,MARQUIS,CONCERTO,PROTECTA,SECURA,CONSULTA,GEM,AND ONYX FAMILIES OF ICDS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.1

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC, ATLAS, EPIC II, AND ATLAS II ICD FAMILIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)

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

FDA Pre-Market Approval

FDA Class 3 ·Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01

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

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-D, Maximo II CRT-D, Protecta XT CRT-D and Protecta CRT-D