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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.
 
DeviceFamily of SCS IPGs
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS213
Date Received03/29/2024
Decision Date06/26/2024
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 AuthorizedYes
Approval Order Statement  
Approval for: • Version 4.00 of the Patient Controller Application to be run on the Android OS that combines the two Patient Controller Applications approved in P010032/S187 (Patient Controller Application version 3.11) and P010032/S202 (Patient Controller Application version 2.00). • Predetermined Change Control Plan (PCCP) of the Patient Controller Application version 4.00 to be run on the Apple iOS.
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