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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.
 
DeviceMOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP990064
Supplement NumberS010
Date Received09/23/2004
Decision Date11/18/2004
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 FOR ADDITIONAL PRODUCT LINES OF THE MOSAIC PORCINE BIOPROSTHESIS AND THE HANCOCK II BIOPROSTHESIS WHICH WILL USE SMALLER SEWING RING DIAMETERS.
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