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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 and Intellis; Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS379
Date Received09/13/2017
Decision Date10/06/2017
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  
Change to the chemical used for the chrome silicon (CrSi) via etch process for the l .5 um HD BiCMOS and 0.8 um HV BiCMOS IC technologies.
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