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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 PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantON-X TECHNOLOGIES, INC
PMA NumberP000037
Supplement NumberS029
Date Received08/23/2012
Decision Date09/19/2012
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the limulus amebocyte lysate (lal) test method and procedure.
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