BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Pacemaker

    PMA: P150035 · Supplement: S026 · Decision Feb 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Leadless Pacemaker
    Trade Name
    Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular)
    PMA Number
    P150035
    Supplement Number
    S026
    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
    February 19, 2026
    Date Received
    May 12, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)

    Classifications

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

    Product Code Device Name
    PNJ Leadless Pacemaker