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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.
 
DeviceIntellis Spinal Cord Stimulation Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS478
Date Received11/19/2020
Decision Date12/17/2020
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  
Update the surface finishing process of the Header Connector part for the Master Intellis Spinal Cord Stimulation Systems; Model Numbers 97715 and 97716, from a tumble finishing operation to a laser finishing operation. Consolidate two inspection test methods to one test method for the Header Connector.
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