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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.
 
DeviceProclaim SCS Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS187
Date Received05/23/2022
Decision Date08/19/2022
Product Code LGW 
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 version 3.11 of the Clinician Programmer and Patient Controller applications which merge previously approved software features into a single version and include minor enhancements and administrative updates. This Real Time Review also requests approval for four new Proclaim SCS Implantable Pulse Generator (IPG) models (models 3670, 3671, 3672, and 3673).
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