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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 MODEL 2500P
Classification Nametubing, pump, cardiopulmonary bypass
Generic Namereplacement heart valve
Regulation Number870.4390
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP000007
Supplement NumberS004
Date Received09/27/2004
Decision Date12/29/2004
Product Code
DWE[ Registered Establishments with DWE ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative liquid sterilant processing solution.
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