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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 Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
PMA NumberP980043
Supplement NumberS034
Date Received06/04/2012
Decision Date01/10/2013
Product Code
DYE[ Registered Establishments with DYE ]
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 the glutaraldehyde stock solution that is obtained from dow chemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution.