PMA supplement
P130024 S009: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
FDA PMA supplement · Panel Track · Lutonix
Key facts
| Original PMA | P130024 |
|---|---|
| Supplement number | S009 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LUTONIX 035 DRUG COATED BALLOON PTA CATHETER |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Lutonix |
| Product code | ONU |
| Received date | Jan 4, 2016 |
| Decision date | Feb 7, 2017 |
| Docket number | 17M-0831 |
| Notice date | Feb 15, 2017 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: