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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
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
Medtronic, Inc.
1851 east deere ave.
santa ana, CA 92705
PMA NumberP980043
Supplement NumberS005
Date Received09/23/2004
Decision Date11/18/2004
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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