BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990075 · Supplement: S016 · Decision Jul 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
    PMA Number
    P990075
    Supplement Number
    S016
    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
    July 27, 2005
    Date Received
    June 27, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) NEW STYLE 2000 MODERATE PLUS PROFILE, WHICH IS CONSIDERED A MODIFICATION TO THE EXISTING PRODUCT INE, WITH SIZES 175CC-800CC; 2) ADDITIONAL SIZES OF 400CC, 450CC, 500CC, 600CC, 650CC AND 800CC FOR STYLE 1600; AND 3) ADDITIONAL SIZES OF 350CC, 400CC, 700CC, 770CC, AND 800CC FOR STYLE 3000. THERE ARE NO CHANGES TO THE INDICATIONS FOR USE.

    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