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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.
DeviceProdigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS189
Date Received07/15/2022
Decision Date01/24/2023
Product Codes LGW QRB 
Docket Number 23M-0399
Notice Date 02/15/2023
Advisory Committee Neurology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for expanding the indications to include diabetic peripheral neuropathy (DPN) of the lower extremities for the tonic stimulation mode.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness