BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P800012 · Supplement: S008 · Decision Mar 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    DRILAC GRANULES
    PMA Number
    P800012
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LPG
    Generic Name
    MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 5, 2002
    Date Received
    January 31, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT KENSEY NASH CORPORATION, EXTON, PENNSYLVANIA. THE GRANULATION AND SYRINGE CUTTING PROCESSES WILL BE CONDUCTED AT THIS FACILITY.

    Classifications

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

    Product Code Device Name
    LPG Material, Dressing, Surgical, Polylactic Acid