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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 NameENDURANT AND ENDURANT II STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMedtronic Vascular
PMA NumberP100021
Supplement NumberS038
Date Received06/09/2014
Decision Date07/08/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for introducing a lamp mandrel as a manufacturing tool for radiopaque contralateral gate marker inspection of endurant and endurant ii bifurcated stent grafts and a coil dispenser as a visual aid during the pre-kitting process of endurant ii stent grafts.
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