PMA
P070015: XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
FDA PMA · Coronary drug-eluting stent · Abbott Vascular, Inc.
Key facts
| PMA number | P070015 |
|---|---|
| Trade name | XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS |
| Generic name | Coronary drug-eluting stent |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NIQ |
| Approval date | Jul 2, 2008 |
| Docket number | 08M-0535 |
| Notice date | Oct 7, 2008 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 100–999 Supplements
- Mar 24, 2021 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- No Withdrawn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: