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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 IMPLANTABLE INFUSION PUMPS
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS105
Date Received03/02/2009
Decision Date05/14/2009
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of visual inspections of the pump septums in manufacturing.
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