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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 Family of Implantable Pulse Generators
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS027
Date Received07/28/2017
Decision Date03/11/2018
Product Codes NHL MHY 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 for a manufacturing site located at St. Jude Medical-Puerto Rico, Lot A Interior-No. 2 St. Km 67.5, Santana Industrial Park, Arecibo, Puerto Rico for manufacturing and sterilization of the Proclaim and Infinity neurostimulation systems.
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