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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 NumberS602
Date Received07/17/2025
Decision Date08/14/2025
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 Tegra Medical to add Unisteel as a secondary supplier for Brass Hubs and Caps used in the needle assembly for Spinal Cord Stimulation (SCS) therapy related lead implant procedures.
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