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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
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP990064
Supplement NumberS002
Date Received08/01/2000
Decision Date08/29/2000
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE VENDOR OF THE POLYESTER YARN USED IN THE MANUFACTURE OF THE MOSAIC PORCINE BIOPROSTHESIS. ALSO, INCLUSION OF THE PMA PRODUCT IN THE "MASTER SUBMISSION" SUBMITTED APRIL 3, 1998 TO P970031/S006 FREESTYLE AORTIC BIOPROSTHESIS. THE INFORMATION CONTAINED IN THE "MASTER SUBMISSION" IS DIRECTLY APPLICABLE TO THE POLYESTER YARN VENDOR CHANGE.
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