BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Computer-Assisted Personalized Sedation System

    PMA: P080009 · Supplement: S011 · Decision Feb 12, 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
    S011
    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
    February 12, 2016
    Date Received
    November 18, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software changes to pulse oximeter artifact mitigation period, redundant pulse oximetry signal quality advisory, allotted time for pulse oximeter synchronization (reset and return to normal operation), and the ability to select Clinician Response (manual) mode after starting treatment using automated response mode.

    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