Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply DR, Esprit SR, Esprit DR

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

FDA Pre-Market Approval

FDA Class 3 ·Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval

FDA Class 3 ·ENUCLENE CLEANING/LUBRICATING SOLUTION

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval

FDA Class 3 ·ENUCLENE(R) OPHTHALMIC SOLUTION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD

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

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene® Microfibrillar Collagen Hemostat

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Micra VR/AV Application

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Platform, CareLink SmartSync Host Application, CareLink SmartSync Common Application, CareLink SmartS

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISCOVERY/MERIDIAN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·CYBERONICS VNS THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application