Evoke® SCS System
FDA premarket approval P190002/S026 · decided 2024-02-29
Approval details
- PMA number
- P190002
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evoke® SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2024-02-05
- Decision date
- 2024-02-29
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- to utilize an alternate second tier supplier to supply a sub-component of the EPO-TEK 301 epoxy due to the discontinuation of the raw material from the original supplier
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