DEL006 NUDEL STENT DELSYS 2.2 16 2.5 12F

DEL006 NUDEL STENT DELSYS 2.2 16 2.5 12F
NuDEL - 614565

A non-bioabsorbable tubular device intended to be implanted in a non-specific region of the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is a mesh structure made of metal (e.g., platinum, iridium) that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft). It is typically expanded in situ (e.g., balloon-expandable) and disposable devices associated with implantation may be included.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PNF

Device Name: Aortic Stent

Device Class: 3

Physical State: The stent is metal and is offered in a range of diameters

Definition: Coarctation of the Aorta

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: An expandable stent is placed in the aorta to keep the vessel open

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Aorta

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 04046955218486

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A