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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 PUMP
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS111
Date Received08/10/2009
Decision Date09/09/2009
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Automating the step where data is transferred from the alarm test equipment to factoryworks, the manufacturing software that controls the manufacturing of the device.
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