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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 NameHANCOCK PORCINE BIOPROSTHETIC HEART VALVE
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
Applicant MEDTRONIC INC.
PMA NumberP870078
Supplement NumberS004
Date Received04/06/1998
Decision Date08/20/1998
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate polyester for use in the sewing ring of the three heart valves.
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