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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATS OPEN PIVOT BILEAFLET HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
MEDTRONIC ATS MEDICAL, INC.
3800 annapolis lane, suite 175
plymouth, MN 55447
PMA NumberP990046
Supplement NumberS001
Date Received10/17/2000
Decision Date05/10/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR VALVE SIZES 16/19 MM AORTIC AND 24/27 MM MITRAL AND THE ADDITION OF A VALVE RESTERILIZATION INSTRUCTION IN THE LABELING.
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