NeuroPace® RNS® System
FDA premarket approval P100026/S091 · decided 2022-12-29
Approval details
- PMA number
- P100026
- Supplement
- S091
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NeuroPace® RNS® System
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2022-09-26
- Decision date
- 2022-12-29
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Approval to use a second contract sterilizer for the ethylene oxide (EO) sterilization of RNS System products.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEUROPACE BURR HOLE COVER (K141368) | NeuroPace, Inc. | 2014-07-11 |
| NEUROPACE BURR HOLE COVER MODEL 8110 (K123163) | NeuroPace, Inc. | 2013-01-18 |