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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP010041
Date Received08/01/2001
Decision Date06/24/2002
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 03M-0086
Notice Date 03/07/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the carpentier-edwards s. A. V. Bioprosthesis, model 2650 (aortic), which includes sizes 21, 23, 25 and 27mm. This device is indicated for patients who require replacement of their native or prosthetic aortic valve.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 
S038 S039 S041 S042 
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