BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P970013 · Supplement: S015 · Decision May 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Sensor Driven, Implantable
    Trade Name
    MICRONY FAMILY OF PACEMAKERS
    PMA Number
    P970013
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    LWO
    Generic Name
    Pulse-generator, single chamber, sensor driven, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2007
    Date Received
    December 20, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).

    Classifications

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

    Product Code Device Name
    LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable