PMA supplement
P110019 S080: XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
FDA PMA supplement · 135 Review Track For 30-Day Notice · Abbott Vascular
Key facts
| Original PMA | P110019 |
|---|---|
| Supplement number | S080 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS |
| Generic name | Coronary drug-eluting stent |
| Applicant | Abbott Vascular |
| Product code | NIQ |
| Received date | Nov 16, 2015 |
| Decision date | Apr 27, 2016 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: