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

    Prosthesis, Testicular

    PMA: P020003 · Supplement: S010 · Decision Aug 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Prosthesis, Testicular
    Trade Name
    Coloplast Saline-Filled Testicular Prosthesis (Torosa)
    PMA Number
    P020003
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    FAF
    Generic Name
    Prosthesis, testicular
    Regulation Number
    876.3750
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 24, 2022
    Date Received
    July 27, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of the Kinetic Turbidimetric method to perform Bacterial Endotoxin testing for the Coloplast Saline-Filled Testicular Prosthesis (Torosa).

    Classifications

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

    Product Code Device Name
    FAF Prosthesis, Testicular