|Trade Name||MEDTRONIC SYNCHROMED INFUSION|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||synchromed & isomed implantable infusion pumps|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes: 1) adding a sutureless pump connector to both models 8709 and 8731 catheters compatible with the synchromed and isomed implantable infusion pumps; 2) adding numbers (in centimeters) to the markings on the 8709 catheter body like those on the 8731 catheter; 3) adding a shorter (9. 3 cm) introducer needle to the model 8731 kit; 4) adding connector pins and strain relief sleeves to model 8731 catheter kit allowing the pump segment of the catheter to be trimmed; 5) create model 8578 as a revision kit for 8709 or 8709sc (sutureless connector) containing the sutureless connector segment and strain relief sleeves; 6) adding model 8598a for current 8598 kit (8731 spinal catheter segment revision kit) modified to contain the shorter (9. 3 cm) introducer needle; and 7) model 8596sc as the pump connector in the current 8596 kit (8731 pump catheter segment revision kit) was replaced with the sutureless pump connector.