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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 NumberS029
Date Received08/28/2019
Decision Date09/19/2019
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  
Implementation of an additional bonding step to the manufacturing process of the printed circuit board assembly to provide reinforcement to the interface between the micro USB connector and the circuit board.
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