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 | Eluvia Drug-Eluting Vascular Stent System |
Generic Name | Stent, superficial femoral artery, drug-eluting |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P180011 |
Supplement Number | S046 |
Date Received | 10/01/2021 |
Decision Date | 12/23/2021 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02574481
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the introduction of a 150mm length Eluvia device, reintroduction of 180mm and 200mm Innova devices, and delivery system shaft modifications. |
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