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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.
 
DeviceProclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS232
Date Received02/05/2025
Decision Date02/21/2025
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  
to qualify an additional production line at a new manufacturing site in Huizhou, China, for the purposes of completing the backend processing of resistors used in the hybrid component of Abbott’s Orion and Gemini implantable pulse generators
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