BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tester, Pacemaker Electrode Function

    PMA: P980023 · Supplement: S010 · Decision Aug 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Tester, Pacemaker Electrode Function
    Trade Name
    ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)
    PMA Number
    P980023
    Supplement Number
    S010
    Device Class
    FDA Class 2
    Product Code
    DTA
    Generic Name
    TESTER, PACEMAKER ELECTRODE FUNCTION
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 30, 2002
    Date Received
    July 22, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE PCMCIA SOFTWARE CARTRIDGE INCLUDING AN INCREASE IN MEMORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) AND IS INTENDED TO ALLOW INTERROGATION AND PROGRAMMING OF BIOTRONIK ICD'S AND PACEMAKERS.

    Classifications

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

    Product Code Device Name
    DTA Tester, Pacemaker Electrode Function