PMA supplement
P150003 S093: SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY™ SHIELD Everolimus-Eluting Plat
FDA PMA supplement · Real-Time Process · Boston Scientific Corporation
Key facts
| Original PMA | P150003 |
|---|---|
| Supplement number | S093 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY™ SHIELD Everolimus-Eluting Plat |
| Generic name | Coronary drug-eluting stent |
| Applicant | Boston Scientific Corporation |
| Product code | NIQ |
| Received date | Mar 14, 2023 |
| Decision date | Jun 12, 2023 |
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: