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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.
 
DeviceDeep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS140
Date Received08/14/2026
Decision Date09/11/2026
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  
approval to utilize an alternate third-tier supplier for the FR-4 material, which is used in the manufacture of the printed circuit boards for the Chargers of the Eterna SCS IPG and Liberta RC DBS IPG
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