BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: P990004 · Supplement: S022 · Decision Jul 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    SURGIFLO HEMOSTATIC MATRIX
    PMA Number
    P990004
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    LMF
    Generic Name
    Agent, absorbable hemostatic, collagen based
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2012
    Date Received
    June 18, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATION FOR USE STATEMENT.PRIOR IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION, IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARLERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. NEW IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION,IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL METHODS 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
    LMF Agent, Absorbable Hemostatic, Collagen Based