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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 NumberS028
Date Received06/28/2012
Decision Date02/13/2013
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified aortic sewing cuff as an extension to the line of available valves; the request applied to the aortic sizes of 19, 21, 23, 25, and 27/29 mm. The device, as modified, will be marketed under the trade name on-x aortic prosthetic heart valve with anatomic sewing ring, and will be given the model designations of onxan (standard valve holder) and onxane (extended valve holder).
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