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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 IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS611
Date Received09/19/2025
Decision Date10/16/2025
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 update to Energy and Components Center (MECC), specifically to update the Programmable Logic Controller (PLC) software to correct an AddUser function on the Medium Rate (MR) Cell Operating Fill Station (COS).
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