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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
PMA NumberP060025
Supplement NumberS003
Date Received01/05/2009
Decision Date03/05/2009
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for extension of the shelf-life of the ats 3f aortic bioprosthesis, model 1000 valves (sizes 19, 21, 23, 25, 27 and 29 mm) from 2 years to 5 years. The device is indicated for ¿. Use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their valve with a prosthetic device. The usual conditions of advanced disease include aortic stenosis, aortic incompetence, and a combination of the two. ¿.