BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Adhesion, Cardiovascular

    PMA: P070005 · Supplement: S002 · Decision May 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Barrier, Adhesion, Cardiovascular
    Trade Name
    REPEL-CV
    PMA Number
    P070005
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    OBD
    Generic Name
    Barrier, adhesion, cardiovascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 5, 2011
    Date Received
    March 7, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

    Classifications

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

    Product Code Device Name
    OBD Barrier, Adhesion, Cardiovascular