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

    Prosthesis, Breast, Inflatable, Internal, Saline

    PMA: P990075 · Supplement: S032 · Decision Apr 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Prosthesis, Breast, Inflatable, Internal, Saline
    Trade Name
    MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
    PMA Number
    P990075
    Supplement Number
    S032
    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
    April 29, 2015
    Date Received
    April 2, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.

    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