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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.
 
DeviceHANCOCK MO VALVED CONDUITS, MODEL 150
Generic Nameheart-valve, non-allograft tissue
ApplicantMEDTRONIC HEART VALVES
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP790007
Supplement NumberS018
Date Received04/13/2007
Decision Date05/10/2007
Product Code LWR 
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 TO THE SUPPLIER OF THE POLYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
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