| 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. |
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| Device | Saluda Medical Evoke SCS System |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Saluda Medical Pty, Ltd.
Level 1, 407 Pacific Hwy.
Atarmon NSW 2064 |
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| PMA Number | P190002 |
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| Supplement Number | S012 |
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| Date Received | 05/16/2022 |
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| Decision Date | 05/05/2023 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for changes which include:1) Modification of the implanted pulse generator (IPG) without changes to delivered therapy;2) Modification of the external Closed-Loop Stimulator (eCLS) to be consistent with the new IPG features and to replace obsolete components;3) Firmware and Software changes to: a. Simplify use of Clinical Software, b. Improve usability and user interface during programming, and c. Improve traceability.4) Change from Surface Pro 4 to Surface Pro 6 as hardware platform for the Clinical Interface due to obsolescence; and5) Minor labelling updates to reflect the proposed changes to the IPG, firmware, and software. |
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