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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.
 
Device4CH & 8CH Infinity DBS System FLex Extension
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS038
Date Received05/04/2018
Decision Date02/14/2019
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 for five changes to specific steps within the manufacturing process of the 4 and 8 Channel Infinity DBS System Flex Extensions (Models 6355, 6356, 6359, 6371, 6372, and 6373).
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