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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™ Extension Kit
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS410
Date Received09/27/2021
Decision Date10/27/2021
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to the Proximal Body Assembly (PBA), which includes increasing the PBA core pin outer diameter tolerance and allowing replacement of PBA tensile test samples when there is a tubing break below the required acceptance criteria, for the SenSight Directional Lead System (Octave) extension subassemblies at the Medtronic Danvers, MA facility.
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