PMA supplement
P030025 S086: TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P030025 |
|---|---|
| Supplement number | S086 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) |
| Generic name | Coronary drug-eluting stent |
| Applicant | Boston Scientific Corp |
| Product code | NIQ |
| Received date | Mar 8, 2010 |
| Decision date | Feb 22, 2012 |
| Docket number | 12M-0209 |
| Notice date | Mar 7, 2012 |
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: