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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.
 
Device8-channel adapter, M, 10cm; 8-channel adapter, M, 60cm; 8-channel adapter, B, 10cm; 8-channel adapter, B, 60cm; Legacy M
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS245
Date Received11/03/2025
Decision Date02/11/2026
Product Codes QRB LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Introduction of the manufacturing aid and stabilizer phosphoric acid to the Bionate raw material (55D PCU, 55D IMG, and 75D)
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