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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:  S047 S038 S037 S032 S028 S042 S043 S027 S009 S010 S004 
S006 S021 S020 S008 S007 S001 S003 S025 S026 S036 S044 S029 
S039 S041 S033 S034 S035 S030 S040 S031 S014 S005 S011 S013 
S022 S019 S016 S017 S018 S045 S046 S048 S052 S058 S049 S050 
S051 S054 S056 S057 S065 S062 S060 S066 S059 S063 S064 S069 
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