BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P120011 · Supplement: S007 · Decision Oct 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
    PMA Number
    P120011
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    FWM
    Generic Name
    Prosthesis, breast, inflatable, internal, saline
    Regulation Number
    878.3530
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 20, 2016
    Date Received
    September 21, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i.e., packaged and sterilized) implants during commercial production start-up, will be discontinued. However, valve competence testing on valves in finished implants will continue to meet the requirements of the AQL sampling specified in Ideal Implant’s Finished Product Specification FP 001.

    Classifications

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

    Product Code Device Name
    FWM Prosthesis, Breast, Inflatable, Internal, Saline