| 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 (Monorail™) |
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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 | S055 |
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| Date Received | 10/28/2019 |
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| Decision Date | 05/28/2020 |
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| Product Code |
NIQ |
| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT03350542
|
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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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
Approval for 48 mm device lengths for the 2.50 to 4.00 mm devices along with modifications to the delivery catheter design and changes to the packaging design. The device, as modified, will be marketed under the trade name SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >= 2.25 mm to <= 5.0 mm in diameter in lesions <= 44 mm in length. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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