|
Device | ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC Inc. 3576 UNOCAL PLACE SANTA ROSA, CA 95403-1774 |
PMA Number | P060033 |
Supplement Number | S042 |
Date Received | 09/02/2009 |
Decision Date | 10/30/2009 |
Withdrawal Date
|
06/06/2016 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |