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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 NumberS014
Date Received09/30/2022
Decision Date09/22/2023
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling change to the following implantable components of the Saluda Evoke Spinal Cord Stimulation (SCS) System as Magnetic Resonance (MR) Conditional for head and extremities (1.5 or 3.0 T) and full body (1.5 T):1) Evoke Closed Loop Stimulator Kit;2) Evoke CAP12 Percutaneous Leads Kit – 60/90cm;3) Evoke 12C Percutaneous Leads Kit – 60/90cm;4) Evoke Spares Kit;5) Evoke Active Anchor Kit; and6) Evoke CAP12X Lead Extension Kit – 55cm.
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