|
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 | S004 |
Date Received | 02/26/2019 |
Decision Date | 05/02/2019 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to extend the shelf life of your device from 18 months to 24 months. |