System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN LEAD DRUG COMBINATION: 4193 & 4194 ONLY/INSYNC CRT-P/INSYNC III CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter Spinal Cord

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Implantable Penile Prosthesis (with and without InhibiZone Treatment) / AMS Ambicor Implantable Penile Prosthesi

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CARDIAC RESYNCHRONIZATION THERAPY (CRT) AND SITUS OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) LEAD

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM & PERCLOSE A T 6F SUTURE-MEDIATED CLOSURE SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD, SPECTRA, NOVI, MONTAGE MRI & PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL3,SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR INPLANTABLE NEUROSTIMULATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter and Safire TX Ablation Catheter