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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 NumberS002
Date Received07/12/2001
Decision Date03/26/2002
Product Code
DWE[ Registered Establishments with DWE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the size 29 mm prima plus stentless bioprosthesis.
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