Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RX5000 PROGRAMMER MODEL 522-12

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM ASD Occluder

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ILIAC ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC AND SAFIRE ABLATION CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT ENDOPROTHESIS NATIVE CORONARY INDICATION

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene® Cryotherapy Device

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST,PREMIER, PREVAIL, VITATRON LEGACY SR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, ANALYZER, VITATRON LEGACY, VITATRON

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System