NeuroPace® RNS® System
FDA premarket approval P100026/S089 · decided 2021-12-16
Approval details
- PMA number
- P100026
- Supplement
- S089
- Supplement type
- 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
- 2021-11-24
- Decision date
- 2021-12-16
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Add an existing NeuroPace supplier as an alternate supplier to manufacture the PEEK Connector Cover part of the Connector Cover Assemblies and Connector Cover Kits for the RNS Neurostimulators (Model RNS-320 and RNS-300M) and to manufacture this part by injection molding rather than by the current machining process.
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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 |