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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 II PORCINE BIOPROSTHESIS, MODELS T505 AND T510
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
Applicant MEDTRONIC INC.
PMA NumberP980043
Supplement NumberS015
Date Received11/13/2007
Decision Date12/12/2007
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a caution statement to the labeling.
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