Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S033 · decided 2024-11-07
Approval details
- PMA number
- P190002
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Saluda Medical Evoke® SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2024-10-01
- Decision date
- 2024-11-07
- Days to decision
- 37 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- to move the final packaging and labeling of the Evoke Charger Kit from Saluda (AU) to Integer/CCC
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