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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 NumberS018
Date Received06/12/2017
Decision Date11/28/2018
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for new MR Conditional labeling limited to transmit/receive head coils and head scans only for the implanted components of the Algovita SCS System.
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