BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040022 · Supplement: S003 · Decision May 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIOLINK VASCULAR CLOSURE SYSTEM
    PMA Number
    P040022
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 24, 2007
    Date Received
    March 8, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INCORPORATION OF THE FOLLOWING PROCESSING AND MATERIAL CHANGES TO THE DISTAL END OF THE VCS 1000 DILATOR: 1) CHANGE IN THE DILATOR MATERIAL FROM NYLON 11 TO PEBAX NYLON 4033 FOR THE DILATOR DISTAL TIP AND FROM NYLON 11 TO PEBAX NYLON 6033 FOR THE DILATOR DISTAL SHAFT; 2) ADDITION OF A RF AND/OR ALTERNATIVE THERMAL ENERGY SOURCE TO BOND THE DILATOR DISTAL TIP TO THE DISTAL SHAFT; AND 3) ADDITION OF A HEAT SHRINK SLEEVE TO ENHANCE THE BOND BETWEEN THE SHAFT AND THE DISTAL TIP.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGB Device, Hemostasis, Vascular