BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pacemaker/Icd/Crt Non-Implanted Components

    PMA: P150035 · Supplement: S028 · Decision Sep 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pacemaker/Icd/Crt Non-Implanted Components
    Trade Name
    AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T
    PMA Number
    P150035
    Supplement Number
    S028
    Device Class
    FDA Class 3
    Product Code
    OSR
    Generic Name
    Pacemaker/icd/crt non-implanted components
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 24, 2025
    Date Received
    June 27, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the AVEIR Remote Care System ECG Feature

    Classifications

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

    Product Code Device Name
    OSR Pacemaker/Icd/Crt Non-Implanted Components