Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 23 mm / Rapid-Exchange

Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 23 mm / Rapid
ABSORB GT1 - 1235350-23

A bioabsorbable tubular or coil-shaped device with a drug coating intended to be implanted, via a delivery catheter, into a de novo or restenotic native coronary artery during a percutaneous coronary intervention (PCI) to temporarily maintain its patency, typically in patients with symptomatic atherosclerotic heart disease. The drug is intended to release slowly to inhibit restenosis by reducing vessel smooth muscle cell proliferation. The device is made of a material capable of being degraded and absorbed by body tissues (e.g., bioabsorbable polymer) and is designed to remain in the vessel to provide support for the stenosed lesion until it degrades.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PNY

Device Name: Absorbable Coronary Drug-Eluting Stent

Device Class: 3

Physical State: Mesh tube in various lengths and diameters

Definition: An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Provides mechanical support to the treated artery and a drug agent to prevent restenosis of the treated artery, and then gradually dissolves and is absorbed by the body.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Coronary arteries

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 08717648213137

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