Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S016 · decided 2023-04-04
Approval details
- PMA number
- P190002
- Supplement
- S016
- 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
- 2023-03-06
- Decision date
- 2023-04-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Move a Printed Circuit Board (PCB) reflow process used to manufacture the Evoke Intraoperative Cable and Lead Adapter from the Artarmon facility to the Macquarie Park facility and to change the legal address on all labeling from Artarmon to Macquarie Park.
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