PMA supplement
P130024 S031: LUTONIX 035 Drug Coated Balloon PTA Catheter
FDA PMA supplement · Normal 180 Day Track No User Fee · Lutonix
Key facts
| Original PMA | P130024 |
|---|---|
| Supplement number | S031 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | LUTONIX 035 Drug Coated Balloon PTA Catheter |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Lutonix |
| Product code | ONU |
| Received date | Sep 23, 2019 |
| Decision date | Mar 20, 2020 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: