BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aspiration Therapy System

    PMA: P150024 · Supplement: S003 · Decision Sep 13, 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
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    OYF
    Generic Name
    Aspiration therapy system
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 13, 2016
    Date Received
    August 15, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a Skin-Port manufacturing in-process leak test.

    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