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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 NameOPEN PIVOT AORTIC VALVED GRAFT
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
Applicant MEDTRONIC INC.
PMA NumberP990046
Supplement NumberS027
Date Received03/08/2012
Decision Date04/03/2012
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding text to the open pivot aortic valved graft instructions for use (ifu) to strengthen the cauterization precaution statement.
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