BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transvenous Temporary Phrenic Nerve Stimulator

    PMA: P240012 · Supplement: S003 · Decision Sep 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transvenous Temporary Phrenic Nerve Stimulator
    Trade Name
    AeroPace® System
    PMA Number
    P240012
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    SDL
    Generic Name
    Transvenous temporary phrenic nerve stimulator
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 29, 2025
    Date Received
    August 20, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software changes to the breath detection algorithm and baseline pressure calculation.

    Classifications

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

    Product Code Device Name
    SDL Transvenous Temporary Phrenic Nerve Stimulator