G ARMOR COVERED GC8Z57

G ARMOR COVERED GC8Z57
G-ARMOR STENT® - 614817

A non-bioabsorbable tubular device intended to be implanted in 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 made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

No Data Available

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: 04046955768035

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