Saluda Medical Evoke® SCS System; Implantable Pulse Generator (Model 3042)
FDA premarket approval P190002/S025 · decided 2024-05-01
Approval details
- PMA number
- P190002
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Saluda Medical Evoke® SCS System; Implantable Pulse Generator (Model 3042)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2024-02-01
- Decision date
- 2024-05-01
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- This supplement requested approval for an alternate battery, the Integer Xcellion® 4210, to be used in the Implantable Pulse Generator (IPG) component of the Saluda Medical Evoke® SCS System.
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