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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 & SYNCHROMED EL IMPLANTABLE PROGRAMMABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS129
Date Received05/25/2010
Decision Date01/14/2011
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a manufacturing site located at benchmark electronics (thailand) public company limited in ayudhaya, thailand for the purchasing of components, receiving inspection, packaging, labeling and final inspection of the model 8529 magnet at this facility.
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