PMA
P210014: SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex
FDA PMA · Coronary drug-eluting stent · Advanced Bifurcation Systems, Inc.
Key facts
| PMA number | P210014 |
|---|---|
| Trade name | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex |
| Generic name | Coronary drug-eluting stent |
| Applicant | Advanced Bifurcation Systems, Inc. |
| Product code | NIQ |
| Approval date | Dec 13, 2021 |
| Docket number | 21M-1321 |
| Notice date | Dec 16, 2021 |
| FEI number | 3008164981 |
At a glance
- 1–9 Supplements
- Apr 6, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: