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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.
 
DeviceSenSight™ Directional Lead Kit
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS407
Date Received08/11/2021
Decision Date09/09/2021
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add a duplicate inspection to the SenSight Lead Stringing Work Instructions for SenSight Lead Coil subassemblies used in models B33005 and B33015. The updated manufacturing process impacts subcomponents for the SenSight Directional Lead occurring at the Medtronic Danvers facility located in Danvers, MA.
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