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 Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) |
Generic Name | Coronary drug-eluting stent |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P150003 |
Supplement Number | S058 |
Date Received | 12/05/2019 |
Decision Date | 08/10/2020 |
Product Code |
NIQ |
Docket Number | 20M-1760 |
Notice Date | 08/14/2020 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02605447
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Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent Systems.The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, 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 <= 5.00 mm in diameter in lesions <= 34 mm in length.The SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at 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 <= 5.00 mm in diameter in lesions <= 44 mm in length and for high risk bleeding patients with coronary arteries >= 2.25 mm to <= 5.00 mm in diameter in lesions <= 34 mm in length. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
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