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

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990075 · Supplement: S013 · Decision Aug 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES
    PMA Number
    P990075
    Supplement Number
    S013
    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 14, 2003
    Date Received
    August 1, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE QUALITY CONTROL TEST SPECIFICATION TO REPLACE THE TENSILE STRENGTH SPECIFICATION WITH A BREAK FORCE SPECIFICATION FOR THE SILICONE ELASTOMER FILL TUBE COMPONENT OF THE MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES.

    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