Premarket Approval (PMA)

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.

• Device: Eluvia Drug-Eluting Vascular Stent System
• Generic Name: Stent, superficial femoral artery, drug-eluting
• Applicant: Boston Scientific Corp; One Scimed Pl.; 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updates to the device labeling.