Devices & Diagnostics > Device

Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 12 mm / Rapid-Exchange


by ABBOTT VASCULAR INC.
Product Overview

Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 12 mm / Rapid
ABSORB GT1 - 1235350-12


Device Description

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.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • -20.00
  • Special Storage Condition, Specify
    • Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • -20.00


    • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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 Identifiers

    Device Id: 08717648213106

    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


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