PMA supplement
P130024 S041: Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter
FDA PMA supplement · 30-Day Notice · Lutonix
Key facts
| Original PMA | P130024 |
|---|---|
| Supplement number | S041 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Lutonix |
| Product code | ONU |
| Received date | Jul 6, 2021 |
| Decision date | Aug 5, 2021 |
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: