BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Computer-Assisted Personalized Sedation System

    PMA: P080009 · Supplement: S009 · Decision Oct 8, 2015
    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
    S009
    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 8, 2015
    Date Received
    September 8, 2015
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATOR¿S MANUAL TO WARN AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS (SPECIFICALLY THOSE CONTAINING AMMONIUM CHLORIDES). ADDITIONALLY, AFFIXING TWO LABELS TO THE EXTERIOR OF THE DEVICE WHICH REITERATE THIS WARNING.

    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