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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.
 
DeviceAlgovita Spinal Cord Stimulation System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNuvectra Corporation
10675 Naples St. NE
Blaine, MN 55449
PMA NumberP130028
Supplement NumberS016
Date Received03/02/2017
Decision Date03/30/2017
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Discontinue the process for evaluation of specific Radiofrequency (RF) parameters, and subsequent approval by Nuvectra based on the RF performance.
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