|
Device | ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS |
Generic Name | Coronary drug-eluting stent |
Applicant | MEDTRONIC Inc. 3576 UNOCAL PLACE SANTA ROSA, CA 95403-1774 |
PMA Number | P060033 |
Supplement Number | S004 |
Date Received | 04/21/2008 |
Decision Date | 05/13/2008 |
Withdrawal Date
|
06/06/2016 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ELIMINATION OF THE ?FINAL INSPECTION PRE-CLEAN? WORK STEP (PRE-PC SPRAY INSPECTION) OF THE PHOSPHORYLCHOLINE (PC) POLYMER BASECOAT SPRAY PROCESS FOR THE ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM. |