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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 MODEL 305 (AORTIC)
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP990064
Supplement NumberS007
Date Received05/06/2002
Decision Date10/28/2002
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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