BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940008 · Supplement: S003 · Decision Aug 22, 1996
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
    PMA Number
    P940008
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 22, 1996
    Date Received
    February 20, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CONSIDER THE INFORMATION PROVIDED IN THIS SUPPLEMENT AS AN ALTERNATIVE RESPONSE TO THE CONDITIONS OF APPROVAL SET FORTH IN THE FDA LETTER DATED NOVEMBER 7, 1995. THE CONDITION REQUIRED THAT REMAINING MINOR SOFTWARE ANOMALIES BE CORRECTED