BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S020 · Decision Aug 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    CODMAN 3000 IMPLANTABLE INFUSION PUMP
    PMA Number
    P890055
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 23, 2007
    Date Received
    August 6, 2007
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE 1) IN PACKAGING LOCATION FOR THE BARBED CATHETER CONNECTOR TO AN IN-HOUSE PROCEDURE AT CODMAN & SHURTLEFF, RAYNHAM, MASSACHUSETTS FROM AVID MEDICAL, ROANO, VIRGINIA, AND 2) CHANGE IN THE BARBED CATHETER CONNECTOR PACKAGING TO THE APPROVED PACKAGING FOR THE FLEX 1 REPLACEMENT CONNECTOR.

    Classifications

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

    Product Code Device Name
    LKK Pump, Infusion, Implanted, Programmable