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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.
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
PMA NumberP060038
Supplement NumberS017
Date Received07/01/2013
Decision Date04/18/2014
Product Code
LWR[ Registered Establishments with LWR ]
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 manufacturing process changes to the mitroflow aortic pericardial heart valve, model lx, consisting of implementation of the phospholipid reduction treatment manufacturing process (an anticalcification treatment process). The device, as modified, will be marketed under the trade name mitroflow aortic pericardial heart valve with phospholipid reduction treatment, model dl and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Post-Approval StudyShow Report Schedule and Study Progress