BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Computer-Assisted Personalized Sedation System

    PMA: P080009 · Decision May 3, 2013
    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
    Device Class
    FDA Class 3
    Product Code
    PDR
    Generic Name
    Computer-assisted personalized sedation system
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 3, 2013
    Date Received
    March 25, 2008
    Expedited Review
    Y
    Docket Number
    13M-0549

    Advisory Committee Statement

    APPROVAL FOR THE SEDASYS® COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM. THIS DEVICE IS INDICATED FOR THE INTRAVENOUS ADMINISTRATION OF 1% (10 MG/ML) PROPOFOL INJECTABLE EMULSION FOR THE INITIATION ANDMAINTENANCE OF MINIMAL TO MODERATE SEDATION, AS DEFINED BY THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) CONTINUUM OF DEPTH OF SEDATION, IN ASA PHYSICAL STATUS I AND II PATIENTS >= 18 YEARS OLD UNDERGOING COLONOSCOPY AND ESOPHAGOGASTRODUOD-DENOSCOPY (EGD) PROCEDURES.

    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