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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.
 
DeviceNeuroSphere Digital Health Apps
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS080
Date Received10/15/2024
Decision Date12/20/2024
Product Code PMP 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for updating the NeuroSphereTM Clinical Programmer (CP) and NeuroSphereTM Patient Controller (PC) applications from version 2.0.2 to version 2.0.3 and the NeuroSphereTM Digital Health App (OneApp) from version 4.0 to version 4.0.1.
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