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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAVALUS(TM) BIOPROSTHESIS
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP170006
Date Received02/02/2017
Decision Date07/31/2017
Product Code LWR 
Docket Number 17M-4756
Notice Date 08/08/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT02088554
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Avalus Bioprosthesis, Model 400. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S030 S031 S032 S033 S034 S036 S037 S038 
S039 S040 S041 S042 
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