BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Material, Dressing, Surgical, Polylactic Acid

    PMA: P840062 · Supplement: S007 · Decision Dec 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Material, Dressing, Surgical, Polylactic Acid
    Trade Name
    HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
    PMA Number
    P840062
    Supplement Number
    S007
    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
    December 7, 2000
    Date Received
    August 18, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL TRADE NAME FOR COLLACOTE, COLLATAPE AND COLLAPLUG. THESE DEVICES WILL ALSO BE KNOWN AS HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY. THE SIZES OF THE WOUND DRESSINGS WILL BE IDENTICAL TO THE THREE COLLACOTE PRODUCTS. THERE WILL BE NO CHANGES IN THE DEVICE EXCEPT THE USE OF AN ADDITIONAL NEW TRADE MANE.

    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