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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 NameEXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
PMA NumberP960009
Supplement NumberS107
Date Received12/27/2010
Decision Date01/26/2011
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the manufacturing of a component flex circuit.
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