Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S019 · decided 2024-03-20
Approval details
- PMA number
- P190002
- Supplement
- S019
- Supplement type
- Panel Track
- 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
- 2024-03-20
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for expanding the indications to include diabetic peripheral neuropathy of the lower extremities
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