BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S042 · Decision Feb 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60)
    PMA Number
    P950037
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 14, 2006
    Date Received
    November 9, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE SELOX SR PACING LEAD FAMILY TO CHANGE THE STEROID DOSAGE, MAXIMUM LEAD BODY DIAMETER, AND RING ELECTRODE BASE MATERIAL, AS WELL AS OTHER MINOR CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD AND IS INDICATED FOR PERMANENT PACING AND SENSING.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable