BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Pacemaker

    PMA: P150033 · Supplement: S201 · Decision Mar 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Leadless Pacemaker
    Trade Name
    Medtronic Micra Transcatheter Pacemaker System
    PMA Number
    P150033
    Supplement Number
    S201
    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
    March 20, 2025
    Date Received
    February 13, 2025
    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 a predetermined change control plan (PCCP) that encompasses the following biocompatibility-related manufacturing changes, provided that they do not impact the properties of the device materials, for the devices under the above PMAs:1. Removal of a processing aid (solvent, lubricant, antifoaming agent, etc.), or cleaning agent2. Removal of a cleaning process3. Change in parameters (temperature, time, sonication, etc.) of a current cleaning process

    Classifications

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

    Product Code Device Name
    PNJ Leadless Pacemaker