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

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990074 · Supplement: S008 · Decision Aug 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS
    PMA Number
    P990074
    Supplement Number
    S008
    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
    August 8, 2001
    Date Received
    July 23, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN MANUFACTURING METHOD. THE CHANGE ADDS AN ALTERNATIVE METHOD FOR A CASTING PROCESS USING THE MOLDING METHOD OF THE STYLE 68 SALINE-FILLED BREAST IMPLANT SHELL COMPONENT USED IN THE FABRICATION OF SALINE-FILLED BREAST IMPLANTS. THERE WILL BE NO CHANGES TO COMPONENT SPECIFICATIONS, DESIGNED PERFORMANCE SPECIFICATIONS OF THE FINISHED DEVICE, OR TO THE PMA DESIGNATED PHYSICAL AND CHEMICAL SPECIFICATIONS OF THE FINISHED DEVICE.

    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