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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 Namebioprosthetic heart valve
Regulation Number870.3925
PMA NumberP860057
Supplement NumberS016
Date Received11/17/2000
Decision Date11/29/2001
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the support assembly components of the size 25, 27, 29, and 31 mm valves. The device, as modified, will be marketed under the trade name carpentier-edwards perimount plus pericardial bioprosthesis, model 6900p and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic mitral heart valves.
Post-Approval StudyShow Report Schedule and Study Progress