NeuroPace® RNS® System
FDA premarket approval P100026/S087 · decided 2023-09-28
Approval details
- PMA number
- P100026
- Supplement
- S087
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NeuroPace® RNS® System
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2021-10-18
- Decision date
- 2023-09-28
- Days to decision
- 710 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Approval to add alternate cleaning equipment and solvent to degrease the Neurostimulator can and Ferrule.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |