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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 Name3F AORTIC BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
ApplicantMEDTRONIC HEART VALVES
PMA NumberP060025
Supplement NumberS011
Date Received03/05/2013
Decision Date04/02/2013
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the labeling regarding the implantation technique for the bioprosthesis.
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