BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Pacemaker

    PMA: P150035 · Supplement: S023 · Decision Jun 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Leadless Pacemaker
    Trade Name
    Aveir Leadless System
    PMA Number
    P150035
    Supplement Number
    S023
    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
    June 17, 2025
    Date Received
    March 19, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.

    Classifications

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

    Product Code Device Name
    PNJ Leadless Pacemaker