Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEM CAP

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEMCAP

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Portico™

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Brio Neurostimulation System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Axium Neurostimulator System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Genesis Neurostimulation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END PIN, ACTIVE CAN EMULATOR HEADER, SIZING & UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACH HEADER, END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alere NMP22 BladderChek Test