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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™ Dorsal Root Ganglion (DRG) IPG
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS083
Date Received02/05/2025
Decision Date02/21/2025
Product Code PMP 
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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