BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990074 · Supplement: S005 · Decision Apr 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    MCGHAN SALINE-FILLED BREAST IMPLANTS
    PMA Number
    P990074
    Supplement Number
    S005
    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
    Approved
    Decision Code
    APPR
    Decision Date
    April 9, 2001
    Date Received
    January 29, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW SERIES OF SIZES FOR THE STYLE 363 SALINE-FILLED BREAST IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLE 363LF AND IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER AND 2) BREAST RECONSTRUCTION.

    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