BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aspiration Therapy System

    PMA: P150024 · Supplement: S016 · Decision Apr 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Aspiration Therapy System
    Trade Name
    Pathway Clinical Trial Cohort
    PMA Number
    P150024
    Supplement Number
    S016
    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
    April 24, 2020
    Date Received
    October 29, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval including the ODE Lead PMA Post-Approval Study - Extended Follow-up of the Premarket Cohort (PATHWAY Clinical Trial) has been fulfilled.

    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