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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 35 MM MITRAL 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 NumberS017
Date Received01/30/2007
Decision Date07/23/2007
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CUFF CHANGE TO ADD THE 35 MM MITRAL VALVE TO THE APPROVED MITRAL VALVE SIZES.
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