CMCP074 Mtd Cvrd CP Stent 6 14 6 8F
CP Stent™ - 614553
Device Description
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.
Environmental Conditions
- KEEP AWAY FROM SUNLIGHT
- 45.00
- 5.00
Device Sizes
- Length : 60.000 MM
- Diameter (mm) : 14.000 MM
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 04046955195756
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