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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.
 
DeviceMOSAIC PORCINE BIOPROSTHESIS
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 NumberS018
Date Received06/19/2007
Decision Date08/29/2007
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to reduce the bioprosthesis rinsing time prior to implantations. The request applies to all sizes of the aortic and mitral mosaic bioprosthesis.
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