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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.
 
DeviceDorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS095
Date Received04/01/2026
Decision Date06/30/2026
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  
updated design verification testing, including fluid ingress evaluations, for the Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generators (IPG) header seals that were approved under P150004/S052.
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