BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S021 · Decision Jul 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
    PMA Number
    N18286
    Supplement Number
    S021
    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 9, 2011
    Date Received
    May 9, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN SOME OF THE COMPONENTS CONTAINED IN THE GELFOAM PLUS KIT AS WELL AS THE INTRODUCTION OF AN ALTERNATIVE GELFOAM PLUS KIT GELFOAM PLUS COMPRESSED. THE COMPONENT CHANGES WILL SUBSTITUTE PREFILLED SALINE SYRINGES AND A NEEDLELESS TRANSFER DEVICE FOR THE STANDARD SALINE VIALS AND NEEDLE-SYRINGE. THE COMPONENTS HAVE BEEN CLEARED/ APPROVED PREVIOUSLY. THE PURPOSE OF THE GELFOAM PLUS KIT IS TO PROVIDE THE CONVENIENCE OF CO-PACKAGED COLLAGEN SPONGE, SALINE DILUENT AND HUMAN THROMBIN TO A PHYSICIAN DURING SURGERY.

    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