Neuropace RNS System
FDA premarket approval P100026/S085 · decided 2021-05-24
Approval details
- PMA number
- P100026
- Supplement
- S085
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Neuropace RNS System
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2021-02-23
- Decision date
- 2021-05-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Approval for minor updates to the RNS® Tablet. NeuroPace is requesting approval for addition of Mobile Device Management (MDM) capability on the tablet platform as well as changes to the login requirements for accessing the NeuroPace Programmer Application on the tablet.
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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 |