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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.
 
DeviceATS OPEN PIVOT BILEAFLET HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC ATS MEDICAL, INC.
3800 ANNAPOLIS LANE, SUITE 175
PLYMOUTH, MN 55447
PMA NumberP990046
Date Received07/29/1999
Decision Date10/13/2000
Product Code LWQ 
Docket Number 00M-1570
Notice Date 10/20/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE, STANDARD AORTIC MODEL A500FA 21, 23, 25, 27, AND 29 MM, STANDARD MITROAL MODEL 500DM 29, 31, AND 33 MM, ADVANCED PERFORMANCE (AP) AORTIC MODEL 501DA 18, 20, 22, 24, AND 26 MM, AND AP MITRAL MODEL 510DM 26 AND 28 MM. THE DEVICE IN INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S025  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S016 S017 S018 S019 S020 S021 S022 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 
S054 S056 S057 S058 S059 S060 S062 S063 S064 S065 S066 S069 
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