BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P970013 · Supplement: S077 · Decision Feb 22, 2018
    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
    PMA Number
    P970013
    Supplement Number
    S077
    Device Class
    FDA Class 3
    Product Code
    LWO
    Generic Name
    Pulse-generator, single chamber, sensor driven, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 22, 2018
    Date Received
    January 31, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.

    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