PMA P060033

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S093
Product code: NIQ
Decision date: 2014-12-10
Generic name: Coronary drug-eluting stent
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).

Current openFDA PMA Record#

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S093
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-12-10
Decision code: OK30
Date received: 2014-11-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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).