PMA supplement
P070015 S122: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA PMA supplement · Panel Track · Abbott Vascular, Inc.
Key facts
| Original PMA | P070015 |
|---|---|
| Supplement number | S122 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
| Generic name | Coronary drug-eluting stent |
| Applicant | Abbott Vascular, Inc. |
| Product code | NIQ |
| Received date | Mar 21, 2014 |
| Decision date | Oct 3, 2014 |
| Docket number | 14M-1596 |
| Notice date | Oct 29, 2014 |
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: