BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Computer-Assisted Personalized Sedation System

    PMA: P080009 · Supplement: S012 · Decision Mar 15, 2016
    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
    S012
    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
    March 15, 2016
    Date Received
    December 17, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software changes to address previous software anomalies (modifications to the Bedside Monitoring Unit (BMU) software to address wireless driver-caused shutdowns, BMU software modifications to address noninvasive blood pressure (NIBP) measurements).

    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