PMA supplement
P170030 S064: Orsiro Mission larger diameter stents Ø 4.5 5.0 mm
FDA PMA supplement · Real-Time Process · Biotronik AG
Key facts
| Original PMA | P170030 |
|---|---|
| Supplement number | S064 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Orsiro Mission larger diameter stents Ø 4.5 5.0 mm |
| Generic name | Coronary drug-eluting stent |
| Applicant | Biotronik AG |
| Product code | NIQ |
| Received date | Apr 24, 2026 |
| Decision date | Jul 23, 2026 |
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: