Saluda Medical Evoke SCS System
FDA premarket approval P190002/S008 · decided 2022-05-26
Approval details
- PMA number
- P190002
- Supplement
- S008
- 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
- 2022-04-27
- Decision date
- 2022-05-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Add an alternate manufacturer for the anchors used in the Evoke Spinal Cord Stimulation System.
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