BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    PMA: P030053 · Supplement: S004 · Decision Apr 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
    Trade Name
    MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
    PMA Number
    P030053
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    FTR
    Generic Name
    Prosthesis, breast, noninflatable, internal, silicone gel-filled
    Regulation Number
    878.3540
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 27, 2007
    Date Received
    March 27, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REVISE THE POST-APPROVAL STUDY TO ALLOW FOR THE VOLUNTARY RATHER THAN MANDATORY PARTICIPATION OF ALL PATIENTS, IRRESPECTIVE OF THE TYPE OF IMPLANT (I.E., MEMORYGEL IMPLANT OR SALINE IMPLANTS) THEY RECEIVE.

    Classifications

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

    Product Code Device Name
    FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled