PMA
P170003: LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
FDA PMA · Drug-coated peripheral transluminal angioplasty catheter · Lutonix
Key facts
| PMA number | P170003 |
|---|---|
| Trade name | LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 |
| Generic name | Drug-coated peripheral transluminal angioplasty catheter |
| Applicant | Lutonix |
| Owner/operator | C. R. Bard, Inc. |
| Product code | PRC |
| Approval date | Aug 25, 2017 |
| Docket number | 17M-5334 |
| Notice date | Sep 8, 2017 |
| 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- No Withdrawn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: