PMA supplement
P170003 S008: Lutonix 035 Drug Coated Balloon PTA Catheter
FDA PMA supplement · Normal 180 Day Track No User Fee · Lutonix
Key facts
| Original PMA | P170003 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Lutonix 035 Drug Coated Balloon PTA Catheter |
| Generic name | Drug-coated peripheral transluminal angioplasty catheter |
| Applicant | Lutonix |
| Product code | PRC |
| Received date | Apr 25, 2019 |
| Decision date | Jun 24, 2019 |
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: