|
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 | S011 |
Date Received | 08/30/2019 |
Decision Date | 09/13/2019 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updates to the device labeling. |