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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.
 
DeviceMaster Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™; Specify™
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS628
Date Received05/08/2026
Decision Date06/05/2026
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  
for expansion of incoming electrolyte salt acceptance limits. Specifically, to expand LiAsF6 electrolyte salt moisture content acceptance limit from: = 100 parts per million (ppm) to: = 200 ppm and expand LiAsF6 electrolyte salt insoluble acceptance limit from: = 20 ppm to: = 200 ppm
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