BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S014 · Decision Mar 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM
    PMA Number
    P950022
    Supplement Number
    S014
    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
    March 11, 2002
    Date Received
    January 31, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW DEFIBRILLATION LEAD SYSTEMS AND ACCESSORIES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIAT SERIES 1500 (MODELS 1570, 1571, 1580 AND 1581) DEFIBRILLATION LEAD SYSTEM AND ACCESSORIES (S-65-S, S-65-F, S-65-X, TX-070). THESE DEVICES ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUAL 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)