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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 NameMITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantCARBOMEDICS, INC.
PMA NumberP060038
Supplement NumberS002
Date Received12/29/2008
Decision Date02/27/2009
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing process improvements to the aortic pericardial heart valve model 12. The device, as modified, will be marketed unde the trade name mitroflow aortic pericardial heart valve model lx and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
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