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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 NameEXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP090003
Supplement NumberS013
Date Received07/05/2012
Decision Date08/03/2012
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the aeration cycle time for the 40c ethylene oxide sterilization cycle.
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