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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.
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
one edwards way
irvine, CA 92614
PMA NumberP860057
Supplement NumberS011
Date Received04/22/1999
Decision Date08/28/2000
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 00M-1483
Notice Date 09/11/2000
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval forthe carpentier-edwards perimount pericardial bioprosthesis model 6900 mitral, sizes 25, 27, 29, 31, and 33 mm. This device is indicated for patients who require replacement of their native or prosthetic mitral valve.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling