|
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 | S059 |
Date Received | 01/27/2016 |
Decision Date | 07/22/2016 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to update the labeling for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) for both the Rapid Exchange (RX) and Over-The-Wire (OTW) delivery systems to include the most current clinical follow-up data for the Global RESOLUTE Clinical Trial Program and the Resolute Integrity US (RI-US) Primary Enrollment Group (PEG) Post-Approval Study. |