|
Device | RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS |
Generic Name | Coronary drug-eluting stent |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110013 |
Supplement Number | S016 |
Date Received | 06/17/2013 |
Decision Date | 09/12/2013 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A REVISED ELUTION SPECIFICATION. |