BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S040 · Decision Sep 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131
    PMA Number
    P950022
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 6, 2007
    Date Received
    July 6, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DISTAL TIP CHANGES TO THE RIATA ST OPTIM LEAD FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA STS OPTIM LEAD MODELS 7120, 7121, 7122, 7130 AND 7131, AND ARE INDICATED FOR USE AS TRANSVENOUS, STEROID ELUTING, RIGHT VENTRICULAR DUAL AND SINGLE DEFIBRILLATION COIL LEADS WITH COMPATIBLE PULSE GENERATORS.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)