PMA
P170030: ORSIRO Sirolimus Eluting Coronary Stent System
FDA PMA · Coronary drug-eluting stent · Biotronik AG
Key facts
| PMA number | P170030 |
|---|---|
| Trade name | ORSIRO Sirolimus Eluting Coronary Stent System |
| Generic name | Coronary drug-eluting stent |
| Applicant | Biotronik AG |
| Owner/operator | BIOTRONIK, INC. |
| Product code | NIQ |
| Approval date | Feb 22, 2019 |
| Docket number | 19M-0885 |
| Notice date | Feb 25, 2019 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 10–99 Supplements
- Sep 24, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: