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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 Nametubing, pump, cardiopulmonary bypass
Generic Namereplacement heart valve
Regulation Number870.4390
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP000007
Supplement NumberS003
Date Received11/12/2002
Decision Date05/09/2003
Product Code
DWE[ Registered Establishments with DWE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the replacement of the package temperature indicator to the tagalert electronic temperature indicator (high and low).
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