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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.
 
DeviceDeep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS080
Date Received09/29/2022
Decision Date10/28/2022
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implement two manufacturing changes used in the production of contact assemblies in supplier Bal Seal Engineering, Inc.’s production of contact assemblies, i.e., 1) to qualify alternate welding equipment used to process the spring component of contact assemblies; and 2) to implement visual automated optical inspection for performing the 100% inspection of the spring component's inner diameter.
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