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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.
 
DeviceInfinity Deep Brain Stimulation (DBS) System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS081
Date Received02/06/2023
Decision Date07/27/2023
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to qualify an alternate site and process improvements for an existing supplier that manufactures components for Abbotts SCS Leads, Extensions and Adapters and DBS Adapters.
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