BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990004 · Supplement: S003 · Decision Nov 15, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE
    PMA Number
    P990004
    Supplement Number
    S003
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 15, 2000
    Date Received
    October 2, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW CONFIGURATION (HEMORRHOIDECTOMY SPONGE) OF THE ABSORBABLE GELATIN SPONGE, USP AS WELL AS A NEW BUBBLE WRAP PACKAGE, A CHANGE IN THE STERILIZATION PROCEDURE INVOLVING THE USE OF E-BEAM STERILIZATION, AND SOME MINOR CHANGES TO THE PACKAGE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM(R) ABSORBA LE GELATIN SPONGE, USP, HEMORRHOIDECTOMY SPONGE AND IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT UROLOGIC AND OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.