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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 BIOPROSTHESIS, MODELS 305, 310
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
MEDTRONIC HEART VALVES
1851 east deere ave.
santa ana, CA 92705
PMA NumberP990064
Supplement NumberS014
Date Received02/06/2006
Decision Date06/05/2006
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 MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE MOSAIC MITRAL BIOPROSTHESES, AND 4) THE "INSTRUCTIONS FOR USE": TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER.
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