PMA P060033S060

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S060
Product code: NIQ
Decision date: 2011-04-12
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.

Current openFDA PMA Record

Device: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Applicant: Medtronic, Inc.
PMA number: P060033
Supplement: S060
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2011-04-12
Decision code: APPR
Date received: 2010-11-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.