PMA
P130024: LUTONIX DRUG COATED BALLOON PTA CATETER
FDA PMA · Drug-Eluting Peripheral Transluminal Angioplasty Catheter · Lutonix
Key facts
| PMA number | P130024 |
|---|---|
| Trade name | LUTONIX DRUG COATED BALLOON PTA CATETER |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Lutonix |
| Owner/operator | C. R. Bard, Inc. |
| Product code | ONU |
| Approval date | Oct 9, 2014 |
| Docket number | 14M-1597 |
| Notice date | Oct 14, 2014 |
| Establishment registration | 3006513822 |
| FEI number | 3006513822 |
At a glance
- 10–99 Supplements
- Jul 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: