BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Pacemaker

    PMA: P150033 · Supplement: S067 · Decision May 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Leadless Pacemaker
    Trade Name
    Micra TPS, Micra AV
    PMA Number
    P150033
    Supplement Number
    S067
    Device Class
    FDA Class 3
    Product Code
    PNJ
    Generic Name
    Leadless pacemaker
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 15, 2020
    Date Received
    February 21, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a firmware update for MyCareLink Patient Monitor Models 24950 and 24952 to version M12.0 as well as CareLink Network updates to provide remote monitoring support for Micra AV.

    Classifications

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

    Product Code Device Name
    PNJ Leadless Pacemaker