Saluda Medical Evoke SCS System
FDA premarket approval P190002/S018 · decided 2023-12-19
Approval details
- PMA number
- P190002
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Saluda Medical Evoke SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2023-09-22
- Decision date
- 2023-12-19
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- 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 ter
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