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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.
 
DeviceEterna™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS238
Date Received06/03/2025
Decision Date06/24/2025
Product Code LGW 
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 for the supplier of resistors contained within Abbott’s family of rechargeable Implantable Pulse Generator printed circuit board assemblies to qualify an additional production line, located at Vishay’s site in Huizhou, China, for an existing supplier for completing the backend processing of resistors
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