| 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 | S018 |
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| Date Received | 09/22/2023 |
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| Decision Date | 12/19/2023 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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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
This supplement requested approval for extending the labeled shelf life of the following components of Saluda Medical Evoke ® SCS System from one year to two years: CAP12X Lead Extension Kit, Tunnler, and Epidural Needle 6.5”. Additionally, the sponsor requested approval for removal of the labeling disclaimer related to the biocompatibility uncertainty, which reads, "although FDA has determined that the probable benefits outweigh the probable risks, there remains some uncertainty on the long term systemic toxicity risks of the leads, lead extensions, and anchors of the device. As a condition of approval, FDA is requiring the manufacturer to provide additional long term systemic toxicity information. " |
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