Evoke® SCS System
FDA premarket approval P190002/S003 · decided 2022-10-06
Approval details
- PMA number
- P190002
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evoke® SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2022-03-11
- Decision date
- 2022-10-06
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for a manufacturing site located at Heraeus Medical Components, LLC (HMCW) 5030 Centerville Road Saint Paul, MN US 55127 for the manufacture and packaging of Evoke Percutaneous Leads and Lead Kits, Packaging and labelling of the Evoke Accessories, and Minor manufacturing process changes for the manufacture of Evoke Percutaneous Leads.
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