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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.
 
DeviceMEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC CARDIAC SURGERY
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576
PMA NumberP790018
Supplement NumberS052
Date Received06/09/2009
Decision Date07/09/2009
Withdrawal Date 12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES TO THE BIOBURDEN TESTING AND CHANGE TO THE STERILIZATION TEST METHODS.
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