BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Absorbable, Synthetic, Polyglycolic Acid

    PMA: P840051 · Supplement: S007 · Decision Jan 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148

    Basic Information

    Device Name
    Suture, Absorbable, Synthetic, Polyglycolic Acid
    Trade Name
    MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
    PMA Number
    P840051
    Supplement Number
    S007
    Device Class
    FDA Class 2
    Product Code
    GAM
    Generic Name
    Suture, absorbable, synthetic, polyglycolic acid
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 11, 1996
    Date Received
    December 19, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid