Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON BRILLIANT S+ VDD LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX MODELS 8400, 8402, 8403

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE ENDOCARDIAL PACING LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECT SECURE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REPLACING LASER EQUIPMENT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT VITALITY

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR TREATMENT OF BPH

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI ICD, EVERA S DR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTS ICD, PROTECTS XT ICD, SECURA IC

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE and PROPONENT Pacemaker Devices

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

FDA Pre-Market Approval

FDA Class 3 ·Loctite® 4206™