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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
LivaNova Canada Corp.
5005 north fraser way
burnaby V5J 5
PMA NumberP150011
Date Received03/02/2015
Decision Date01/08/2016
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 16M-0123
Notice Date 01/11/2016
Advisory Committee Cardiovascular
Clinical Trials NCT01368666
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the perceval sutureless heart valve. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005