BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Injectable, Embolic

    PMA: P030004 · Supplement: S017 · Decision Jun 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Agent, Injectable, Embolic
    Trade Name
    Apollo Onyx Delivery Micro Catheter
    PMA Number
    P030004
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    MFE
    Generic Name
    Agent, injectable, embolic
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 15, 2020
    Date Received
    March 1, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a labeling change for the Apollo Onyx Delivery Micro Catheter to include the results of the Apollo Onyx Delivery Micro Catheter Post Market Safety Study (APOLLO PMS).

    Classifications

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

    Product Code Device Name
    MFE Agent, Injectable, Embolic