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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHANCOCK II BIOPROSTHESIS
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP980043
Supplement NumberS012
Date Received06/19/2007
Decision Date08/29/2007
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO REDUCE THE BIOPROSTHESIS RINSING TIME PRIOR TO IMPLANTATION. THE APPROVAL APPLIES TO ALL SIZES OF THE AORTIC AND MITRAL HANCOCK II BIOPROSTHESIS.
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