|
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 | S092 |
Date Received | 07/22/2014 |
Decision Date | 10/17/2014 |
Withdrawal Date
|
06/06/2016 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL OF UPDATES TO THE INSTRUCTIONS FOR USE TO ACCURATELY REFLECT THE CORRECT SAFETY FACTORS FOR THE ZOTAROLIMUS DRUG SUBSTANCE. |