BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P990030 · Decision Jun 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Absorbable Collagen Hemostatic Agent With Thrombin
    Trade Name
    VITAGEL SURGICAL HEMOSTAT
    PMA Number
    P990030
    Device Class
    FDA Class 3
    Product Code
    PMX
    Generic Name
    Absorbable collagen hemostatic agent with thrombin
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 13, 2000
    Date Received
    June 7, 1999
    Expedited Review
    N
    Docket Number
    00M-1368

    Advisory Committee Statement

    APPROVAL FOR COSTASIS(R) SURGICAL HEMOSTAT AND DYNASTAT(TM) SURGICAL HEMOSTAT. THIS DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

    Classifications

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

    Product Code Device Name
    PMX Absorbable Collagen Hemostatic Agent With Thrombin