|
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 | S113 |
Date Received | 10/06/2020 |
Decision Date | 05/13/2021 |
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 increased post dilatation diameters and changes to the delivery system |