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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS107
Date Received12/27/2010
Decision Date01/26/2011
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES TO THE MANUFACTURING OF A COMPONENT FLEX CIRCUIT.
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