# Lutonix: PMA supplement approved for Lutonix™ 035 Drug Coated Balloon Catheter

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Lutonix |
| Product | Lutonix™ 035 Drug Coated Balloon Catheter |
| Generic / ingredient | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Approval | PMA supplement (device change) |
| Application | P130024 S045 |
| Decided | 2026-07-09 |
| Panel / class | Cardiovascular |
| Sponsor location | New Hope, MN |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130024S045). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.