Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·Inform HER2 Dual ISH DNA Probe Cocktail

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Voltage Ceramic Capacitors

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Thoracic Stent Graft With the Captivia Delivery System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, Viva CRT-P

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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

FDA Pre-Market Approval

FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 IQFISH PHARMDX

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Tridyne Vascular Sealant

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV/VR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE. IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R)

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM CRT-D 1711/1741