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 Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary
• Generic Name: Coronary drug-eluting stent
• Applicant: ABBOTT VASCULAR; 3200 Lakeside Drive; Santa Clara, CA 95054
• PMA Number: P110019
• Supplement Number: S115
• Date Received: 12/28/2020
• Decision Date: 06/25/2021
• Product Code: NIQ
• Docket Number: 21M-0656
• Notice Date: 07/06/2021
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for the XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), and the XIENCE Skypoint Everolimus Eluting Coronary Stent System (XIENCE Skypoint EECSS).The XIENCE [Alpine / Sierra / Skypoint] stent system is indicated for improving coronary artery luminal diameter in patients, including those at high risk for bleeding and those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length <= 32 mm) with reference vessel diameters of >= 2.25 mm to <= 4.25 mm. In addition, the XIENCE [Alpine / Sierra / Skypoint] stent system is indicated for treating de novo chronic total coronary occlusions.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2