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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 II INFUSION SYSTEM
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS112
Date Received08/21/2009
Decision Date09/18/2009
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Automation of the transfer of final functional test data to factoryworks, the manufacturing software that controls the manufacturing of the device.
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