PMA
P100044: PROPEL
FDA PMA · Drug-eluting sinus stent · Intersect Ent.
Key facts
| PMA number | P100044 |
|---|---|
| Trade name | PROPEL |
| Generic name | Drug-eluting sinus stent |
| Applicant | Intersect Ent. |
| Owner/operator | Medtronic, Inc. |
| Product code | OWO |
| Approval date | Aug 11, 2011 |
| Docket number | 11M-0600 |
| Notice date | Aug 19, 2011 |
| Establishment registration | 3008301917 |
| FEI number | 3008301917 |
At a glance
- 10–99 Supplements
- Sep 23, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: