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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 NumberS006
Date Received04/13/2016
Decision Date05/13/2016
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  
Optional replacement of a diode hand-soldering process with an automated surface mount technology process and optional replacement of an uncoated wire with a zero Ohm resistor on the printed circuit boards for the Model 4200 patient programmer charger of your Algovita Spinal Cord Stimulation system.
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