PMA supplement
P110019 S115: XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary
FDA PMA supplement · Panel Track · Abbott Vascular
Key facts
| Original PMA | P110019 |
|---|---|
| Supplement number | S115 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary |
| Generic name | Coronary drug-eluting stent |
| Applicant | Abbott Vascular |
| Product code | NIQ |
| Received date | Dec 28, 2020 |
| Decision date | Jun 25, 2021 |
| Docket number | 21M-0656 |
| Notice date | Jul 6, 2021 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: