|
Device | ENDEAVOR SPRINT 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 | S075 |
Date Received | 04/26/2013 |
Decision Date | 10/15/2013 |
Withdrawal Date
|
06/06/2016 |
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 A CHANGE TO THE EMPOWER SOFTWARE APPLICATION USED TO CONTROL THE ANALYTICAL CHROMATOGRAPHIC INSTRUMENTS FOR THE ANALYTICAL TESTS. |