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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.
 
Trade NameMOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC)
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC HEART VALVES
PMA NumberP990064
Supplement NumberS007
Date Received05/06/2002
Decision Date10/28/2002
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the valve holders for the mosaic bioprosthesis. The holders are to be used with the following approved valve models and sizes: mosaic porcine bioprosthesis, model 305 (aortic, sizes 19, 21, 23, 25, 27, and 29 mm. These aortic valves are indicated for the replacement of malfunctioning native or prosthetic aortic valves.
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