Saluda Medical Evoke SCS System
FDA premarket approval P190002/S006 · decided 2022-05-12
Approval details
- PMA number
- P190002
- Supplement
- S006
- 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
- 2022-04-12
- Decision date
- 2022-05-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Change in the sterilization process at Steris Applied Sterilization Technologies (Steris AST) by increased load density, reduction of injection pressure of EO gas (reduction in EO concentration), and updated chamber temperature specification and tolerances.
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