NeuroPace RNS System
FDA premarket approval P100026/S047 · decided 2017-08-14
Approval details
- PMA number
- P100026
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NeuroPace RNS System
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2017-02-15
- Decision date
- 2017-08-14
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Approval for the Neurostimulator (model RNS-320), NeuroPace Programmer (model 5000), Patient Data Management System (PDMS, model 4340), and Remote Monitor (model 5100).
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 |