Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S001 · decided 2022-10-26
Approval details
- PMA number
- P190002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2022-03-03
- Decision date
- 2022-10-26
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval to move the current cleanroom facilities located at 14 Mars Rd, Lane Cove, NSW, Australia (Lane Cove) to 5 Eden Park Drive, Macquarie Park, NSW, Australia (Macquarie Park) and approval to duplicate external device production from the current Artarmon facility (407 Pacific Highway, Artarmon, NSW, Australia) to the Macquarie Park facility.
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