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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 Spinal Cord Stimulation Implantable Pulse Generator
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS234
Date Received03/11/2025
Decision Date06/09/2025
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 1) qualifying an alternate Gemini implanted pulse generator (IPG) feedthrough supplier, Integer, along with associated design change, in which the alumina in the ceramic portion of the feedthrough is increasing in level of purity; and 2) qualifying an optional Gemini IPG Can buffing step at current IPG Can supplier, National Manufacturing, to remove cosmetic defect marks on the IPG Can.
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