| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi |
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| Generic Name | Coronary drug-eluting stent |
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| Applicant | Boston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311 |
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| PMA Number | P150003 |
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| Supplement Number | S105 |
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| Date Received | 07/31/2024 |
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| Decision Date | 01/27/2025 |
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| Product Code |
NIQ |
| Docket Number | 25M-0347 |
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| Notice Date | 01/31/2025 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT03048825
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, ST-elevation MI (STEMI), non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ?2.25 mm to ?5.00 mm in diameter in lesions ?34 mm in length. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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