Impra® ePTFE Cardiovascular Patch 25 mm x 150 mm, Regular wall


Product Overview

Impra® ePTFE Cardiovascular Patch 25 mm x 150 mm, Regular wall
Impra® ePTFE Cardiovascular Patch - 25P15006


Device Description

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).


Environmental Conditions

No Data Available


Device Sizes

  • Thickness, 0.6 Millimeter
  • Length: 150 Millimeter
  • Width: 25 Millimeter
    • Thickness, 0.6 Millimeter
    • Length: 150 Millimeter
    • Width: 25 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DXZ

    Device Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 870.3470

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00801741041488

    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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