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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
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
Applicant MEDTRONIC INC.
PMA NumberP980043
Supplement NumberS030
Date Received02/15/2011
Decision Date04/15/2011
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label.
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