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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
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantON-X TECHNOLOGIES, INC
PMA NumberP000037
Supplement NumberS017
Date Received11/17/2009
Decision Date01/14/2010
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the material specifications for the sewing cuff ptfe fabric used in the assembly of the on-x valve.
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