SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro
FDA premarket approval P150003/S090 · decided 2023-03-02
Approval details
- PMA number
- P150003
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-12-07
- Decision date
- 2023-03-02
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the introduction of an alternative resin material (ReZilok Rx 101) supplied by existing BSC-approved supplier Compounding Solutions.
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510(k) clearances by this applicant
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| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
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| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
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| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |