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

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S062 · Decision May 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.
    PMA Number
    P890055
    Supplement Number
    S062
    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
    May 27, 2016
    Date Received
    April 27, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change for a new packaging equipment to seal the pouches for the Codman 3000 Constant-Flow Implantable Infusion Pump O.R. Prep Kit Tubing Assembly. External supplier, Command Medical Products (Command), has requested implementation of new packaging sealing equipment, a Sencorp bar sealer (12-PL/2) with a removable work surface. The supplier has requested the change as a process improvement.

    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