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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, mechanical
Generic Nameheart-valve, mechanical
3905 annapolis lane, suite 105
plymouth, MN 55447
PMA NumberP990046
Date Received07/29/1999
Decision Date10/13/2000
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 00M-1570
Notice Date 10/20/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S013 S014 S016 S017 S018 S019 S020 S021 
S022 S025 S026 S027 S028 S029 S030 S031 S032 
S033 S034 S035 S036 S037 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S047