BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transvenous Temporary Phrenic Nerve Stimulator

    PMA: P240012 · Supplement: S005 · Decision Feb 20, 2026
    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
    S005
    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
    February 20, 2026
    Date Received
    January 23, 2026
    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) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240012.

    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