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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 NameSYNCHROMED INFUSION SYSTEMS, SYNCHROMED, SYNCHROMED II, SYNCHROMED EL
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS177
Date Received10/05/2012
Decision Date12/17/2012
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes to model 8840 n'vision programmer software for end of service and low/empty reservoir alarms and is indicated for use with synchromed el and synchromed ii pumps.
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