Saluda Medical Evoke SCS System
FDA premarket approval P190002/S043 · decided 2025-07-10
Approval details
- PMA number
- P190002
- Supplement
- S043
- 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
- 2025-06-12
- Decision date
- 2025-07-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- A change to the supplier provided NP34 Xhale adhesive formulation applied to Tyvek lids which are used in the packaging of Saluda lead, anchor and spares kits.
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