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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Aspiration Therapy System

    PMA: P150024 · Decision Jun 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Aspiration Therapy System
    Trade Name
    AspireAssist
    PMA Number
    P150024
    Device Class
    FDA Class 3
    Product Code
    OYF
    Generic Name
    Aspiration therapy system
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 14, 2016
    Date Received
    July 8, 2015
    Expedited Review
    N
    Docket Number
    16m-1754

    Advisory Committee Statement

    Approval for the AspireAssist® is intended to assist in weight reduction of obese patients. It is indicated for use in adults aged 22 or older with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The AspireAssist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.

    Classifications

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

    Product Code Device Name
    OYF Aspiration Therapy System