BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S167 · Decision Feb 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR
    PMA Number
    P860004
    Supplement Number
    S167
    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
    February 17, 2012
    Date Received
    December 27, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SUTURELESS CONNECTOR (SC) CATHETER MODELS 8709SC AND 8731SC, AND REVISION KIT MODELS 8578 AND 8596SC TO ADDRESS THE POTENTIAL FOR SIDE LOAD LEAKS. THE MODIFICATION TO YOUR SUTURELESS CONNECTOR ARE AS FOLLOWS: 1) DECREASED THE COUNTER BORE DIAMETER FROM 0.040" TO 0.035"; 2) DECREASED THE DEPTH OF THE COUNTER BORE FROM 0.055" TO 0.050"; 3) INCREASED THE TOLERANCE FOR THE 0.15" DIMENSION OF THE TUBING POSITION FROM +-0.01 TO +-0.02; AND 4) ADDED A REQUIREMENT TO THE PRODUCT SPECIFICATION FOR SIDE LOAD FORCES: CONNECTOR MUST NOT OCCLUDE OR LEAK WHEN PRESSURIZED TO 1.0 +- 0.1 PSIG AIR PRESSURE AND A FORCE OF 4.8 +- 0.1 LBF IS DISTRIBUTED OVER THE CONNECTOR SURFACE AT AN ANGLE OF 12 DEGREES +- 2 DEGREES.

    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