PMA
P100026: NEUROPACE RNS SYSTEM
FDA PMA · Implanted brain stimulator for epilepsy · NeuroPace, Inc.
Key facts
| PMA number | P100026 |
|---|---|
| Trade name | NEUROPACE RNS SYSTEM |
| Generic name | Implanted brain stimulator for epilepsy |
| Applicant | NeuroPace, Inc. |
| Owner/operator | NeuroPace |
| Product code | PFN |
| Approval date | Nov 14, 2013 |
| Docket number | 12M-1488 |
| Notice date | Nov 25, 2013 |
| Establishment registration | 3004426659 |
| FEI number | 3004426659 |
At a glance
- 10–99 Supplements
- Aug 19, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: