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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 NumberS001
Date Received08/22/1994
Decision Date01/04/1996
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a name change to the carpentier-edwards perimount bioprosthesis, model 2700, and approval for a reduced sewing ring (rsr) version of the valve which will be named the carpentier-edwards perimount rsr bioprosthesis, model 2800 and approval for the use of the current model 1161 valve sizers with the model 2800 valve, and approval for a new set of valve sizers, model 1127, for use with the model 2700 valve. The approval also discontinues the use fo the current device name, the carpentier-edwards pericardial bioprosthesis. The device, as modified, will be marketed under the trade anem carpentier-edwards perimount bioprosthesis, model 2700, and carpentier-edwards perimount rsr bioprosthesis, model 2800 and will continue to use the same indications for use and remain available in the aortic sizes of 19, 21, 23, 25, 27, and 29mm.