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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP000007
Date Received01/27/2000
Decision Date02/27/2001
Withdrawal Date 01/28/2022
Product Code DYE 
Docket Number 01M-0381
Notice Date 09/05/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE EDWARDS PRIMA(TM) PLUS STENTLESS BIOPROSTHESIS MODEL 2500P, SIZES 21, 23, 25 AND 27 MM. THE DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE USING THE SUBCORONARY IMPLANTATION TECHNIQUE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S041 S026 S040 S030 S035 S036 S037 S044 S029 S004 S005 
S006 S007 S001 S024 S025 S011 S012 S010 S027 S042 S043 S045 
S038 S039 S033 S034 S031 S032 S028 S046 S003 S008 S009 S002 
S014 S015 S021 S018 S013 S016 S017 S022 S023 S019 S020 
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