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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC SYNCHROMED INFUSION
Classification Namepump, infusion, implanted, programmable
Generic Namesynchromed & isomed implantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS081
Date Received01/13/2006
Decision Date03/22/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
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.
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