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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.
 
DeviceSaluda Medical Evoke® 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 NumberS001
Date Received03/03/2022
Decision Date10/26/2022
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 to move the current cleanroom facilities located at 14 Mars Rd, Lane Cove, NSW, Australia (Lane Cove) to 5 Eden Park Drive, Macquarie Park, NSW, Australia (Macquarie Park) and approval to duplicate external device production from the current Artarmon facility (407 Pacific Highway, Artarmon, NSW, Australia) to the Macquarie Park facility.
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