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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 IPG
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS210
Date Received02/05/2024
Decision Date05/02/2024
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for the standardization of the presentation of dimensions of the Liberta RC DBS IPG (model 62400) and the Eterna SCS IPG (model 32400) within device labeling, basing them on nominal specification values via a computer-generated engineering model
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