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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 XR, Proclaim Plus, and Externa 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 NumberS191
Date Received09/02/2022
Decision Date05/10/2023
Product Codes LGW QRB 
Advisory Committee Neurology
Clinical TrialsNCT04479787
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 non-surgical back pain (NSBP) for the tonic and BurstDR stimulation modes, and diabetic peripheral neuropathy (DPN) of the lower extremities for the tonic stimulation mode, for the Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems.
Approval OrderApproval Order
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