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

    PMA: P030017 · Supplement: S228 · Decision Jun 26, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
    PMA Number
    P030017
    Supplement Number
    S228
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 26, 2015
    Date Received
    May 29, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION FOR ALTERNATE TEST EQUIPMENT SYSTEM USED FOR THE TESTING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OF THE CHARGER.