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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC Inc.
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774
PMA NumberP060033
Supplement NumberS089
Date Received02/18/2014
Decision Date03/19/2014
Withdrawal Date 06/06/2016
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGES TO HOW EXTRUDED COMPONENTS ARE PHYSICALLY GROUPED AND TO THE WAY SAMPLES ARE SELECTED FOR IN-PROCESS TESTING.
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