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 Skypoint 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: S125
• Date Received: 04/26/2023
• Decision Date: 07/20/2023
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol as well as Statistical Analysis Plan for the post-approval study (PAS) protocol.