PMA supplement
P070015 S053: XIENCE V RX/PROMUS RX/XIENCE OTW/PROMUS OTW
FDA PMA supplement · 30-Day Notice · Abbott Vascular, Inc.
Key facts
| Original PMA | P070015 |
|---|---|
| Supplement number | S053 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | XIENCE V RX/PROMUS RX/XIENCE OTW/PROMUS OTW |
| Generic name | Coronary drug-eluting stent |
| Applicant | Abbott Vascular, Inc. |
| Product code | NIQ |
| Received date | Nov 15, 2010 |
| Decision date | Dec 7, 2010 |
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: