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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.
 
DeviceInternal Leads Extensions and 8 Chanel Adapters
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS053
Date Received11/27/2019
Decision Date02/22/2021
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add Abbott Medical Puerto Rico facility located at Km 67.5 Rd2 Arecibo, Puerto Rico, 00612 as an alternate sterilization and manufacturing site of the Paddle Lead and Internal Lead Extension products.
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