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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.
 
DeviceSCS EPG 2-Port Header (Model 3042)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS217
Date Received05/01/2024
Decision Date11/22/2024
Product Codes QRB 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 a new external pulse generator (EPG) header design (model 3042) and high-definition multimedia interface (HDMI) extension cable to be incorporated into the SCS EPG Invisible trial system, as well as removal of the SCS multi-lead trial cable (MLTC) (model 3013).
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