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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P050044 · Decision Jun 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Absorbable Collagen Hemostatic Agent With Thrombin
    Trade Name
    VITAGEL RT3 SUTGICAL HEMOSTAT
    PMA Number
    P050044
    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    Approved (Withdrawn)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 16, 2006
    Date Received
    November 30, 2005
    Expedited Review
    N
    Docket Number
    06M-0293

    Advisory Committee Statement

    APPROVAL FOR THE VITAGEL SURGICAL HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) 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