|
Device | RESOLUTE INTEGRITY RX & OTW 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 | S040 |
Date Received | 04/25/2014 |
Decision Date | 05/23/2014 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00248079
|
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE STENT SUB-ASSEMBLY MANUFACTURING EQUIPMENT. |
Post-Approval Study | Show Report Schedule and Study Progress |