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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.
 
DeviceRestore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS497
Date Received07/28/2021
Decision Date10/26/2021
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for minor labeling changes for the Models 97715 and 97716 Intellis implantable neurostimulators, Model 977Axxx and 977Dxxx Vectris lead kits, Model 977Cxxx Specify lead kits, and Model 9779x Injex anchor accessory kits which includes removing storage temperature limits from the labeling.
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