Industry News

Thoracic aortic aneurysm stent grafts have been added to the list of devices subject to tracking requirements, according to a final guidance.

Devices which currently require tracking include:
Temporomandibular Joint (TMJ) prosthesis Glenoid fossa prosthesis Mandibular condyle prosthesis Implantable pacemaker pulse generator Cardiovascular permanent implantable pacemaker electrode Replacement heart valve (mechanical only) Automatic implantable cardioverter/defibrillator Implanted cerebellar stimulator Implanted diaphragmatic/phrenic nerve stimulator Implantable infusion pumps Abdominal Aortic Aneurysm (AAA) stent grafts Silicone gel-filled breast implants Cultured epidermal autografts Thoracic Aortic Aneurysm (TAA) stent grafts Breathing frequency monitors Continuous ventilators Ventricular bypass (assist) device DC-defibrillators and paddles.