BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S025 · Decision Jun 3, 2013
    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) POWDER,USP
    PMA Number
    N18286
    Supplement Number
    S025
    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
    June 3, 2013
    Date Received
    April 17, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABEL CHANGES TO THE INSTRUCTIONS FOR USE: FOR THE FOLLOWING DEVICE ITERATIONS:1) GELFOAM PLUS -ORIGINAL SPONGE IFU- NEEDLELESS;2) GELFOAM PLUS- POWDER IFU-NEEDLELESS; 3) GELFOAM PLUS - COMPRESSED SPONGE IFU NEEDLELESS;4) GELFOAM ABSORBABLE GELATIN) SPONGE; 5) GELFOAM (ABSORBABLE GELATIN) DENTAL SPONGE; 6) GELFOAM (ABSORBABLE GELATIN) COMPRESSED SPONGE; AND 7) GELFOAM (ABSORBABLE GELATIN) POWDER.ADD THE PRECAUTIONARY STATEMENT:POSITIONING OF THE PATIENT RESULTING IN NEGATIVE PERIPHERAL VENOUS PRESSURE DURING A PROCEDURE HAS BEEN REPORTED TO BE A CONTRIBUTING FACTOR RESULTING IN LIFE-THREATENING THROMBOEMBOLIC EVENTS.2. FOR THE FOLLOWING DEVICE ITERATIONS:1) GELFOAM (ABSORBABLE GELATIN) SPONGE; 2) GELFOAM (ABSORBABLE GELATIN) DENTAL SPONGE; 3) GELFOAM (ABSORBABLE GELATIN) COMPRESSED SPONGE; AND 4) GELFOAM (ABSORBABLE GELATIN) POWDER.MAKE MINOR CHANGES TO THE EXISTING PRECAUTIONARY STATEMENT: ALTHOUGH THE SAFETY AND EFFICACY OF THE COMBINED USE OF GELFOAM WITH OTHER AGENTS SUCH AS TOPICAL THROMBIN HAS NOT BEEN EVALUATED IN PHARMACIA- CONTROLLED CLINICAL TRIALS, IF IN THE PHYSICIANS JUDGMENT CONCURRENT USE OF TOPICAL THROMBIN OTHER AGENTS IS MEDICALLY ADVISABLE, THE PRODUCT LITERATURE FOR THAT AGENT SHOULD BE CONSULTED FOR COMPLETE PRESCRIBING INFORMATION.

    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