PMA supplement
P180031 S001: Neuroform Atlas® Stent System
FDA PMA supplement · Panel Track · Stryker Neurovascular
Key facts
| Original PMA | P180031 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Neuroform Atlas® Stent System |
| Generic name | Intracranial coil-assist stent |
| Applicant | Stryker Neurovascular |
| Product code | QCA |
| Received date | Jul 22, 2019 |
| Decision date | Jul 30, 2020 |
| Docket number | 20M-1726 |
| Notice date | Aug 3, 2020 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: