PMA supplement
P160049 S019: Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
FDA PMA supplement · 30-Day Notice · The Spectranetics Corp.
Key facts
| Original PMA | P160049 |
|---|---|
| Supplement number | S019 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp. |
| Product code | ONU |
| Received date | Jun 14, 2022 |
| Decision date | Jul 15, 2022 |
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: