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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 NameITREL 3/SYNERGY/RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS146
Date Received01/27/2010
Decision Date02/26/2010
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction in the frequency of routine monitoring in the controlled environment at the medtronic puerto rico operations company, juncos, puerto rico.
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