|
Device | RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM,RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S015 |
Date Received | 06/10/2013 |
Decision Date | 11/07/2013 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO THE COMPONENTS AND THE SOFTWARE OF THE DRUG SPRAY MACHINE. |