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

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS