|
Device | Resolute Integrity Zotarolimus-Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S097 |
Date Received | 06/21/2019 |
Decision Date | 12/18/2019 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01913600
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for changes to the directions for use to include the most currently available long-term clinical follow-up data for the Resolute Integrity US Xl Sub-study. |