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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, Charger, Patient Controller Application, Clinician Programmer Application
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS186
Date Received04/01/2022
Decision Date12/16/2022
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for approval for commercial distribution of Abbotts Eterna Spinal Cord Stimulation (SCS) System. This system consists of a rechargeable Implantable Pulse Generator (IPG), Charging System, and Clinician Programmer Application and Patient Controller Application. These components are intended to be used with commercially available SCS leads, extensions and accessories.
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