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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
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC HEART VALVES
PMA NumberP990064
Supplement NumberS028
Date Received07/31/2009
Decision Date09/29/2009
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design modification to the disposable cinch aortic valve holder. The device, as modified, will be marketed under the trade name cinch ii valve holder and is indicated for the temporary deflection of the valve stent posts to provide surgical ease of implantation of the bioprosthesis.
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