Saluda Medical Evoke SCS System
FDA premarket approval P190002/S005 · decided 2022-07-06
Approval details
- PMA number
- P190002
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Saluda Medical Evoke SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2022-04-08
- Decision date
- 2022-07-06
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for design changes to the lead and stylet used with the Evoke Spinal Cord Stimulation (SCS) System, including decreasing the stylet length by 14mm and removing the epoxy material surrounding the non-active band at the proximal end of the lead.
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