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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 NumberS010
Date Received03/04/2013
Decision Date05/29/2013
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the rinsing and fixations solutions used in the manufacture of the device. The device, as modified, will be marketed under the trade name 3f aortic bioprosthesis, model 1000 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
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