BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S016 · Decision Aug 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
    PMA Number
    P890055
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 12, 2003
    Date Received
    July 16, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) REPLACE THE CURRENTLY APPROVED CATHETER KIT (AP-07002) WITH THE IP-36633 AND IP-3757 KITS, 2) REPLACE IP-36633 AND IP-3757 CONNECTOR WITH CODMAN 3000 (AP-07002) CONNECTOR, AND INCLUDE TITANIUM AS AN ALTERNATIVE CONNECTOR MATERIAL, 3) ADD ADDITIONAL COMPONENTS TO THE KIT AS A CONVENIENCE TO THE PHYSICIANS AND 4) LABELING CHANGE TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT INSTRUCTIONS FOR USE TO REFLECT THE CORRECT CATHETER VOLUME.

    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