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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 NameEDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP000007
Supplement NumberS018
Date Received10/02/2008
Decision Date10/29/2008
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for gluteraldehyde used in the manufacture of tissue heart valves.
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