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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 NameSOLETRA/KINETRA/ACTIVA PC/SC/RC INS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS114
Date Received04/04/2011
Decision Date05/04/2011
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of newly validated process parameters for the blister sealing machine at medtronic puerto rico operations company (mproc) located in juncos, puerto rico.
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