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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 PUMP, MODEL 8637
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS180
Date Received12/05/2012
Decision Date03/04/2013
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the synchromed ii battery capacity specification.
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