BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Pacemaker

    PMA: P150035 · Supplement: S031 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Leadless Pacemaker
    Trade Name
    AVEIR Leadless Pacemaker
    PMA Number
    P150035
    Supplement Number
    S031
    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
    September 5, 2025
    Date Received
    August 14, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of the revised protocol for the post-approval study (PAS) submitted to comply with the conditions of approval outlined in our approval order P910023/S468

    Classifications

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

    Product Code Device Name
    PNJ Leadless Pacemaker