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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 NameON-X ASCENDING AORTIC PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantON-X TECHNOLOGIES, INC
PMA NumberP000037
Supplement NumberS018
Date Received01/04/2010
Decision Date01/14/2011
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at vascutek, ltd. , scotland, great britain (uk). Also approval for a valved conduit. The device, as modified, will be marketed under he trade name on-x ascending aortic prosthesis and is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic heart valve in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
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