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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 and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS371
Date Received08/02/2017
Decision Date08/31/2017
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  
Qualify an alternate BalSeal manufacturing site facility for the spring coil components (Colorado Springs) and to update the tooling used for the insertion testing of the contact assembly from a uni-directional test pin to a bi-directional test pin.
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