BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    PMA: P130010 · Supplement: S004 · Decision Jul 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
    Trade Name
    VEGA R45; VEGA R52; VEGA R58; VEGA R45 RE-INTERVENTION KIT; VEGA R58 RE-INTERVENTION KIT; VEGA R45 RE-INTERVENTION KIT
    PMA Number
    P130010
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    NVN
    Generic Name
    Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 23, 2025
    Date Received
    April 18, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.

    Classifications

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

    Product Code Device Name
    NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes