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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.
 
DeviceSt, Jude Medical Infinity Deep Brain Stimulation (DBS) Leads
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS041
Date Received10/18/2018
Decision Date11/14/2018
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add X-ray inspections during the manufacture of the electrode subassemblies to enhance the safety of the leads for the Infinity Deep Brain Stimulation System.
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