BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P170012 · Decision Dec 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Absorbable Collagen Hemostatic Agent With Thrombin
    Trade Name
    HEMOBLAST™ Bellows
    PMA Number
    P170012
    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
    Decision Code
    APPR
    Decision Date
    December 15, 2017
    Date Received
    March 30, 2017
    Expedited Review
    N
    Docket Number
    17M-6896

    Advisory Committee Statement

    Approval of the Hemoblast Bellows. This device is indicated for surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.

    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