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: XIENCE Sierra Everolimus Eluting Coronary Stent System
• Generic Name: Coronary drug-eluting stent
• Applicant: Abbott Vascular; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P110019
• Supplement Number: S094
• Date Received: 09/01/2017
• Decision Date: 05/22/2018
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for changes to the stent geometry, delivery system, and packaging materials.