BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P960030 · Supplement: S031 · Decision Aug 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS
    PMA Number
    P960030
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 13, 2015
    Date Received
    May 20, 2010
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.

    Classifications

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

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes