|
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 | S024 |
Date Received | 01/21/2020 |
Decision Date | 04/01/2020 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02921230
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the revised protocols for the post-approval studies (PAS) protocol, including terminating enrollment in the REGAL study and extending follow-up to five years for the EMINENT study. |