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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.
 
DeviceEvoke® SCS System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantSaluda Medical Pty, Ltd.
Level 1, 407 Pacific Hwy.
Atarmon NSW 2064
PMA NumberP190002
Supplement NumberS003
Date Received03/11/2022
Decision Date10/06/2022
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Heraeus Medical Components, LLC (HMCW) 5030 Centerville Road Saint Paul, MN US 55127 for the manufacture and packaging of Evoke Percutaneous Leads and Lead Kits, Packaging and labelling of the Evoke Accessories, and Minor manufacturing process changes for the manufacture of Evoke Percutaneous Leads.
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