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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 Pl.
Santa Rosa, CA 95403
PMA NumberP060033
Supplement NumberS017
Date Received10/20/2008
Decision Date11/19/2008
Withdrawal Date06/06/2016
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES TO THE ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM: 1) REUSE OF CATHETER HOOPS; 2) ELIMINATE PRE-PC SPRAY INSPECTION WORK STEP; 3) WELDING PROCESS AUTOMATION; 4) ALTERNATIVE POUCH SEALING EQUIPMENT; 5) CHANGE TO STENT STORAGE AND TRANSPORTATION VIAL; AND 6) CONICAL SPRAY JAR ASSEMBLY.
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