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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Applicant MEDTRONIC INC.
PMA NumberP060033
Supplement NumberS017
Date Received10/20/2008
Decision Date11/19/2008
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
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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