BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polyethylene

    PMA: N16374 · Supplement: S036 · Decision Jun 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    233
    Registration Numbers
    233

    Basic Information

    Device Name
    Suture, Nonabsorbable, Synthetic, Polyethylene
    Trade Name
    PRONOVA ABSORABLE SUTURE, USP
    PMA Number
    N16374
    Supplement Number
    S036
    Device Class
    FDA Class 2
    Product Code
    GAT
    Generic Name
    Suture, nonabsorbable, synthetic, polyethylene
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 1999
    Date Received
    December 21, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the PRONOVA Non-absorbable Suture manufactured from poly (vinylidene fluoride) and poly (vinylidene fluoride-co-hexafluoropropylene). The device, as modified, will be marketed under the trade name PRONOVA and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

    Classifications

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

    Product Code Device Name
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene