BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pacemaker/Icd/Crt Non-Implanted Components

    PMA: P910077 · Supplement: S144 · Decision Aug 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Pacemaker/Icd/Crt Non-Implanted Components
    Trade Name
    VENTAK PRX AND VENTAK MINI SYSTEMS
    PMA Number
    P910077
    Supplement Number
    S144
    Device Class
    FDA Class 3
    Product Code
    OSR
    Generic Name
    Pacemaker/icd/crt non-implanted components
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 12, 2014
    Date Received
    June 9, 2014
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODEL 2909 MULTIPLE APPLICATION UTILITY SYSTEM SOFTWARE V9.03 AND MODEL 2905 PDF REPORT GENERATION SOFTWARE V1.02 WHICH RESIDE ON THE ZOOM LATITUDE PROGRAMMING SYSTEM MODEL 3120.

    Classifications

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

    Product Code Device Name
    OSR Pacemaker/Icd/Crt Non-Implanted Components