|
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 | S093 |
Date Received | 11/10/2014 |
Decision Date | 12/10/2014 |
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 OPTION TO STERILIZE USING CYCLE #3 ON LINES 9 AND 3, CHANGING THE RESOLUTE INTEGRITY¿S PALLET CONFIGURATION, AND CO-STERILIZATION OF ALL SIMILAR DES DEVICES (INCLUDING THOSE COMMERCIALIZED OUTSIDE OF US). |