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

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    PMA: P100033 · Supplement: S003 · Decision Apr 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prostrate Cancer Genes Nucleic Acid Amplification Test System
    Trade Name
    PROGENSA PCA3 ASSAY
    PMA Number
    P100033
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    OYM
    Generic Name
    Prostrate cancer genes nucleic acid amplification test system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 16, 2015
    Date Received
    March 19, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURING SCALE UP OF BULK ENZYME RECONSTITUTION SOLUTION (P/N BS0421), BY ALLOWING BULKING AND FILLING FROM LARGER TANKS (208L AND 303L) AND ADDITIONALLY, TOEXTEND THE BULK HOLD TIME FROM 7 DAYS UP TO 1 MONTH TO ALLOW SUFFICIENT TIME FOR THE SOLUTION TO BE USED WITHIN MANUFACTURING.

    Classifications

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

    Product Code Device Name
    OYM Prostrate Cancer Genes Nucleic Acid Amplification Test System