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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 NumberS034
Date Received12/16/2024
Decision Date01/14/2025
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  
to update the bioburden alert and action limits to align with historical data for the Evoke CAP12 Percutaneous Lead and Trial Lead Kits, Evoke Spares Kit, Evoke Active Anchor Kit, Evoke Active Anchor Kit – L, Evoke CAP12X Lead Extension Kit – 55cm, Evoke Intraoperative Cable, Evoke Epidural Needle and Evoke Tunneler
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