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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 SYSTEMS
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC Inc.
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774
PMA NumberP060033
Supplement NumberS072
Date Received10/03/2012
Decision Date11/20/2012
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 THE ORIENTATION OF THE STERILIZATION CARTONS, LOCATION OF THE INTERNAL PROCESS CHALLENGE DEVICES, AND MODIFICATIONS TO THE EXTERNAL PROCESS CHALLENGE DEVICES USED DURING STERILIZATION.
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