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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/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR GALWAY LIMITED
PMA NumberP060033
Supplement NumberS039
Date Received08/07/2009
Decision Date09/03/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the storage time for exposed biological indicators prior to testing.
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