PMA supplement
P170030 S039: ORSIRO Mission Sirolimus Eluting Coronary Stent System
FDA PMA supplement · Special (Immediate Track) · Biotronik AG
Key facts
| Original PMA | P170030 |
|---|---|
| Supplement number | S039 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ORSIRO Mission Sirolimus Eluting Coronary Stent System |
| Generic name | Coronary drug-eluting stent |
| Applicant | Biotronik AG |
| Product code | NIQ |
| Received date | May 10, 2024 |
| Decision date | Jun 6, 2024 |
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: