Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX MODELS 8400, 8402, 8403

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·TRIVISC

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 IPG

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC BIOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-CORE-IGMK PLUS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR/MODEL 2020A MEDTRONIC CARDIOSIGHT READER/MODEL 2020B CARELINK EXPRES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-MAK-2 PLUS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY/THERA-I PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD 2 LEAD, VITATRON BRILLIANT S+ VVD LEAD

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2