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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.
 
DeviceGenesis Neurostimulation System
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS181
Date Received10/01/2021
Decision Date11/03/2021
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Consolidate the Electrical testing at the cleaning step and QC inspection step of the manufacturing process and for the consolidated step to be performed after the Weld tip/Leak test step using automated CAMI lead test system in the Abbott Medical Puerto Rico, LLC manufacturing site.
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