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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 SCS and Proclaim SCS Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS237
Date Received05/09/2025
Decision Date01/13/2026
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for labeling changes to expand the ‘Magnetic Resonance (MR) Conditional’ labeling to include prone positioning for the Eterna and Proclaim SCS Systems, as well as update the radiofrequency (RF) heating conditions and lead tip implant location for supine positioning for the Proclaim SCS System to ensure consistency in the labeling between the Eterna and Proclaim SCS Systems
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