Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D,Amplia MRI Quad CRTD, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D,Cobalt MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI VR ICD, Mirro MRI DR ICD,

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

FDA Pre-Market Approval

FDA Class 3 ·PROSTATRON

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS FAMILY OF PULSE GENERATORS

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

FDA Pre-Market Approval

FDA Class 3 ·THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO & ENTRUST

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER, AND AMPLATZER ¿CRIBRIFORM¿ OCCLUDER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OMNISCEINCE PROSTHETIC CARDIAC VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST PULSE GENERATORS MODEL 7026/7027

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 4968

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS