PMA
P180031: Neuroform Atlas® Stent System
FDA PMA · Intracranial coil-assist stent · Stryker Neurovascular
Key facts
| PMA number | P180031 |
|---|---|
| Trade name | Neuroform Atlas® Stent System |
| Generic name | Intracranial coil-assist stent |
| Applicant | Stryker Neurovascular |
| Owner/operator | STRYKER CORP. |
| Product code | QCA |
| Approval date | May 16, 2019 |
| Docket number | 19M-2408 |
| Notice date | May 20, 2019 |
| Establishment registration | 3008881809 |
| FEI number | 3008881809 |
At a glance
- 10–99 Supplements
- Jun 24, 2025 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- No Withdrawn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: