BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Ablation Catheter, Renal Denervation

    PMA: P220026 · Supplement: S015 · Decision Feb 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Ablation Catheter, Renal Denervation
    Trade Name
    Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
    PMA Number
    P220026
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    QYI
    Generic Name
    Ablation catheter, renal denervation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 27, 2026
    Date Received
    January 30, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to the e-beam sterilization equipment, and process monitoring at the sterilization contractor

    Classifications

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

    Product Code Device Name
    QYI Ablation Catheter, Renal Denervation