BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P050011 · Supplement: S006 · Decision Jun 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    ADEPT Adhesion Reduction Solution
    PMA Number
    P050011
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 3, 2019
    Date Received
    May 17, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a transfer of the design-owning organization from Baxter AG Vienna, Austria to Baxter Alliance Park Braine-L'Alleud, Belgium and final release testing and product release functions from Baxter AG Vienna, Austria to Baxter Castlebar, Ireland for the ADEPT Adhesion Reduction Solution.

    Classifications

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

    Product Code Device Name
    MCN Barrier, Absorbable, Adhesion