BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Computer-Assisted Personalized Sedation System

    PMA: P080009 · Supplement: S002 · Decision Oct 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Computer-Assisted Personalized Sedation System
    Trade Name
    SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
    PMA Number
    P080009
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    PDR
    Generic Name
    Computer-assisted personalized sedation system
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 2014
    Date Received
    May 28, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

    Classifications

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

    Product Code Device Name
    PDR Computer-Assisted Personalized Sedation System