BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S041 · Decision Oct 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND
    PMA Number
    P950022
    Supplement Number
    S041
    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
    October 16, 2007
    Date Received
    August 22, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE SHOCK COIL ON THE RIATA ST OPTIM AND RIATA STS OPTIM LEADS AND TO ADD TWO NEW PASSIVE LEAD MODELS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA ST OPTIM LEAD MODELS 7020, 7021, 7022, 7030, 7031, 7070 AND 7071 AND RIATA STS OPTIM LEAD MODELS 7120, 7121,7122, 7130, 7131, 7170 AND 7171 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUL FOR SYSTEM INDICATIONS). THEY PROVIDE PACING AND SENSING AND DELIVER CARDIOVERSION/ DEFIBRILLATION THERAPY TO THE HEART.

    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)