BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ablation Catheter, Renal Denervation

    PMA: P220023 · Decision Nov 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Ablation Catheter, Renal Denervation
    Trade Name
    Paradise® Ultrasound Renal Denervation System
    PMA Number
    P220023
    Device Class
    FDA Class 3
    Product Code
    QYI
    Generic Name
    Ablation catheter, renal denervation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 7, 2023
    Date Received
    October 25, 2022
    Expedited Review
    N
    Docket Number
    23M-4937

    Advisory Committee Statement

    The Paradise Ultrasound Renal Denervation System is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.

    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