BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950037 · Supplement: S008 · Decision Aug 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    ACTROS+ FAMILY OF PULSE GENERATORS
    PMA Number
    P950037
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 24, 1999
    Date Received
    March 1, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator