|
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 | S028 |
Date Received | 03/12/2020 |
Decision Date | 05/19/2020 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization. |