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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 S
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS486
Date Received03/22/2021
Decision Date06/07/2021
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to Model 977D160 Vectris® 1x8 SC (Subcompact) Trial Screening Lead and Model 977D260 Vectris® 1x8 Compact Trial Screening Lead, to add an alternate material, 304 stainless-steel wire, for the braided shield of the Vectris lead body.
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