PMA P060033S073

Device
Endeavor Sprint Zotarolimus-eluting Coronary Stent
Applicant
MEDTRONIC Inc.
PMA number
P060033
Supplement
S073
Decision date
2013-03-27

Current openFDA PMA Record

Device
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant
Medtronic, Inc.
PMA number
P060033
Supplement
S073
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2013-03-27
Decision code
OK30
Date received
2013-03-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM

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