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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 Spinal Cord Stimulation (SCS) IPG Family
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS151
Date Received06/12/2019
Decision Date09/09/2019
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for rebranding the Proclaim Elite device to the Proclaim XR and for changing the company name from SJM to Abbott and approval for revising the labeling to include additional cycling parameters within previously approved cycling range on the 36600, 3661, 3662, and 3663 Proclaim Implanted Pulse Generator models.
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