PMA supplement
P150003 S003: SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL)
FDA PMA supplement · Panel Track · Boston Scientific Corporation
Key facts
| Original PMA | P150003 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL) |
| Generic name | Coronary drug-eluting stent |
| Applicant | Boston Scientific Corporation |
| Product code | NIQ |
| Received date | Dec 7, 2015 |
| Decision date | Jul 29, 2016 |
| Docket number | 16M-2334 |
| Notice date | Aug 18, 2016 |
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: