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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 SYSTEM
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS089
Date Received04/13/2007
Decision Date11/05/2008
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the medtronic model 8835 personal therapy manager (myptm) and the model 37092 detachable antenna.
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