BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S158 · Decision Dec 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II PROGRAMMABLE PUMP
    PMA Number
    P860004
    Supplement Number
    S158
    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
    December 9, 2011
    Date Received
    September 26, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) THE ASSEMBLY PROCESS FOR THE ROLLER SUBCOMPONENT OF THE PUMPHEAD CURRENTLY USES A MANUAL PRESS AND WILL BE CHANGED TO USE A MOTORIZED PRESS THAT MONITORS AND CONTROLS TRAVEL DISTANCE AND ASSEMBLY FORCE. THIS CHANGE IS INTENDED TO IMPROVE YIELD AND MANUFACTURING EFFICIENCY; 2) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR THE PUMPHEAD ASSEMBLY DEFINED AS THE "STOP POSITION" WILL BE CHANGED FROM 10.77 + 0.044/-0.046 MILLIMETERS TO10.77 +/-0.060 MILLIMETERS. THE CRITICAL COMPONENT SPECIFICATION OF FORCE APPLIED BY THE PUMPHEAD ROLLERS ON THE PUMP TUBE IS NOT CHANGING. THIS CHANGE IS INTENDED TO IMPROVE YIELD OF THE PUMPHEAD COMPONENT; AND 3) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR RIVET DIAMETER USED TO ASSEMBLE THE SUPPORT ROLLER ARM SIDES AND SUPPORT ROLLER ARM CENTER IN THE PUMPHEAD ASSEMBLY WILL BE CHANGED FROM 1 +/ -0.002 MILLIMETERS TO 1 +/-0.006 MILLIMETERS. THE RIVETS WILL ALSO BE SORTED BASED ON THE INDIVIDUAL DIAMETER TO MATCH WITH THE DIAMETER OF THE HOLES IN THE ASSEMBLY THEY ARE INSERTED INTO TO PREVENT INTERFERENCE. THE CRITICAL COMPONENT SPECIFICATION OF MINIMUM PRESS OUT FORCE AFTER THE RIVET IS PRESSED INTO PLACE IS NOT CHANGING. THIS CHANGE IS INTENDED TO IMPROVE YIELD OF THE PUMPHEAD COMPONENT.

    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