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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.
 
DeviceMITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL
Generic Nameheart-valve, non-allograft tissue
ApplicantCORCYM Canada Corp.
5005 North Fraser Way
Burnaby V5J 5
PMA NumberP060038
Supplement NumberS017
Date Received07/01/2013
Decision Date04/18/2014
Withdrawal Date 10/17/2022
Product Code LWR 
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 MANUFACTURING PROCESS CHANGES TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, MODEL LX, CONSISTING OF IMPLEMENTATION OF THE PHOSPHOLIPID REDUCTION TREATMENT MANUFACTURING PROCESS (AN ANTICALCIFICATION TREATMENT PROCESS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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