PMA P060033S049

Device
Endeavor Zotarolimus-eluting Coronary Stent System
Applicant
MEDTRONIC Inc.
PMA number
P060033
Supplement
S049
Decision date
2010-04-28

Current openFDA PMA Record

Device
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Applicant
Medtronic, Inc.
PMA number
P060033
Supplement
S049
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2010-04-28
Decision code
APPR
Date received
2010-02-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

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