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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceSpinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS220
Date Received07/01/2024
Decision Date07/26/2024
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
a manufacturing change in supplier Bal Seal Engineering, Inc.'s production of contact assemblies, manufactured for Abbott's IPGs final finished devices. Specifically, during the “weld” step, Bal Seal will process the spring components using either Point-Welded (with current resistance weld process) or Butt-Welded (with proposed laser weld process)
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