Saluda Medical Evoke SCS System
FDA premarket approval P190002/S017 · decided 2024-12-03
Approval details
- PMA number
- P190002
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Saluda Medical Evoke SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2023-06-01
- Decision date
- 2024-12-03
- Days to decision
- 551 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- This is a 180-day supplement, which requested approval for updates of the programming software and stimulator firmware (Closed Loop Stimulator [CLS] and external Closed Loop Stimulator [eCLS]) of the Saluda Medical Evoke® Spinal Cord Stimulation (SCS) System to accommodate the addition of a new software module, the Assisted Programming Module (APM), within the Clarity Programming Application (CPA)
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