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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 System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS200
Date Received07/07/2023
Decision Date10/05/2023
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for software update (from 1.0 to 1.1) of the CP and PC Apps. These apps are used by the clinician and patient, respectively, to program or control the Eterna SCS neurostimulation system. The proposed minor design change will update the CP and PC software to address the incorrect formula assumption and display a battery message after the device is past the current lifetime as defined in the product requirement. This change is being made to address field complaints regarding the PC generating premature ERI messages soon after implant.
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