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

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990074 · Supplement: S003 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    SALINE FILLED BREAST IMPLANT
    PMA Number
    P990074
    Supplement Number
    S003
    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
    December 15, 2000
    Date Received
    November 29, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE PRODUCT LAL TESTING FROM A RELEASE TEST FOR EVERY STERILIZATION LOT, TO A MANUFACTURING CHANGE CONTROL TOOL USED FOR PROCESS AND MATERIAL CHANGES. THERE WILL BE NO ADVERSE EFFECT TO THE DEVICE AS A RESULT OF CHANGING THE LAL TESTING FROM A RELEASE TEST TO A QUALIFICATION TEST. HISTORICAL RECORDS OF LAL TESTING ON FINISHED PRODUCT DEMONSTRATE THE PRODUCT MANUFACTURING PROCESS IS CONTROLLED AND PREDICTABLE, DELIVERING AN ENDOTOXIN-FREE PRODUCT.

    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