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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 2500, 2500P
Classification Nametubing, pump, cardiopulmonary bypass
Generic Namereplacement heart valve
Regulation Number870.4390
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP000007
Supplement NumberS008
Date Received04/28/2005
Decision Date05/20/2005
Product Code
DWE[ Registered Establishments with DWE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the supplier of polyethylene terephthalate (pet) polyester yarn and knitted polyester fabric.
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