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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.
 
DeviceSpinal Cord Stimulation (SCS)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS221
Date Received07/08/2024
Decision Date08/08/2024
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
Approval Order Statement  
supplier-related changes, including 1) an additional raw material supplier of Grade 2 Titanium; and 2) changing the primary dimensional inspection method from the optical gaging product measurement method to the laser inspection method, for the feedthru component within the Eterna Spinal Cord Stimulation Implantable Pulse Generator and Liberta RC Deep Brain Stimulation Implantable Pulse Generator
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