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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
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP860004
Supplement NumberS190
Date Received03/18/2013
Decision Date04/17/2013
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in test sample size for certain connector components provided by the supplier.
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