BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: P990009 · Supplement: S009 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)
    PMA Number
    P990009
    Supplement Number
    S009
    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
    August 10, 2001
    Date Received
    June 26, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM, THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE INDICATIONS STATEMENT AND THE ADDITION OF THE NASAL/SINUS INSTRUCTIONS AND INORMATION TO THE LABELING OF THE "DRY" FORM OF THE FUSION MATRIX PRODUCT.

    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