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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.
 
DeviceItrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris®
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS487
Date Received04/09/2021
Decision Date05/06/2021
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  
Use of an alternate component supplier Meier Tool & Engineering, Inc. for the platinum iridium electrodes used in SCS Leads, Models 39286, 39565, 977C165, 977C190, 977C265, & 977C290. Meier Tool & Engineering, Inc. will form the electrodes using progressive die instead of manual blank/form die. Vanishing Oil 101 will be used in the manufacturing process. Meier Tool & Engineering, Inc. will SQM Inspect the product and Medtronic Villalba will SQM Verify the product.
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