Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphereTM Y-90 Glass Microspheres System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM SYSTEM

Salivary Estriol Test

FDA Pre-Market Approval

FDA Class 3 ·SALEST TM SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

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

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut™ R Transcatheter Aortic Valve, Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve,

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Avalus Bioprosthesis, Model 400

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·FLUORO-CEP (R) PROGESTERONE

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·FLUORO-CEP (R) PROGESTERONE

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·FLUORO-CEP (R) PROGESTERONE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic E

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD; EMBLEM MRI S-ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO; PROPONENT; ACCOLADE MRI

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

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN X4; INOGEN X4; ORIGEN X4; AUTOGEN X4; MOMENTUM X4; VIGILIANT X4; RESONATE X4/HF; PUNCTUA; ENERGEN; INCEPTA CRT-D