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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 NameCARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC
Classification Namereplacement heart-valve
Generic Namebioprosthetic heart valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS018
Date Received10/02/2001
Decision Date11/14/2003
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design and manufacturing modifications to the sewing ring/support assembly components of the model 2800 aortic valve, sizes 19, 21, 23, 25, 27, and 29 mm. The device, as modified, will be marketed under the trade name carpentier-edwards perimount magna pericardial bioprosthesis, model 3000 aortic and is indicated for the replacement of malfunctioning native or prosthetic aortic heart valves using the supra-annular or intra-annular implantation technique.
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