|
Device | XIENCE Skypoint Everolimus Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S118 |
Date Received | 07/01/2021 |
Decision Date | 03/11/2022 |
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 |
Approval Order Statement Approval for approval for two changes to the existing design: 1) additional XIENCE Skypoint sizes, specifically diameters 4.50 mm and 5.0 mm; and 2) a dual neck catheter chassis with dimensional changes to the outer membrane diameters. |
Post-Approval Study | Show Report Schedule and Study Progress |