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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.
 
DeviceDBS System - Lead and Extension
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS084
Date Received06/23/2023
Decision Date02/21/2024
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  
The firm requested approval to qualify a new manufacturing site and process improvements for an existing supplier of materials used in the manufacture of DBS Leads and Extensions and to utilize a new supplier for components used in the manufacture of the DBS Extensions. Based upon the information submitted, the PMA supplement is approved.
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