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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.
 
DeviceDBS Neurostimulation System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS125
Date Received08/27/2025
Decision Date09/25/2025
Product Codes MHY NHL PJS 
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  
the following changes for the shaft of the torque wrench accessory of the approved SCS, DBS, and DRG Neurostimulation systems: 1) Second-tier supplier manufacturing process relocation2) Validation of new, equivalent equipment at new site
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