PMA
P250041: SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
FDA PMA · Drug-eluting percutaneous transluminal coronary angioplasty catheter · MedAlliance, LLC
Key facts
| PMA number | P250041 |
|---|---|
| Trade name | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon |
| Generic name | Drug-eluting percutaneous transluminal coronary angioplasty catheter |
| Applicant | MedAlliance, LLC |
| Product code | OOB |
| Approval date | Sep 18, 2026 |
At a glance
- None Supplements
- Sep 18, 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- No Withdrawn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: