BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910023 · Supplement: S055 · Decision Oct 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER
    PMA Number
    P910023
    Supplement Number
    S055
    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 2, 2001
    Date Received
    September 5, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY 5 DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES.

    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)