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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 and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS496
Date Received07/14/2021
Decision Date08/13/2021
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).
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