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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.
 
DeviceNEUROSTIMULATION SYSTEM FOR DEEP BRAIN STIMULATION (DBS)
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS193
Date Received03/31/2014
Decision Date04/30/2014
Product Code MHY 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO PROVIDE CORRECTIONS TO THE LABELING RELATED TO THE CYCLING FEATURE (ALTERNATING BETWEEN THERAPY OFF AND ON) IN SOME NEUROSTIMULATION DEVICES USED FOR SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
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