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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
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP990064
Supplement NumberS028
Date Received07/31/2009
Decision Date09/29/2009
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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