PMA supplement
P160049 S027: Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon
FDA PMA supplement · Normal 180 Day Track · The Spectranetics Corp.
Key facts
| Original PMA | P160049 |
|---|---|
| Supplement number | S027 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp. |
| Product code | ONU |
| Received date | Aug 29, 2025 |
| Decision date | Nov 24, 2025 |
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: