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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 Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS369
Date Received07/27/2017
Decision Date08/24/2017
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  
Transfer of receiving and incoming inspection activities for device components (i.e., Screw-Conn Set, Crimp Block 7495, and Block- Connector, Set Screw) used in the manufacture of Medtronic Neuromodulation therapy delivery products, from the Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company (MPROC)-Villalba, MPROC-Juncos, and the FedEx/3PL (Third Party Logistics) facility in Guaynabo, Puerto Rico.
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