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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.
 
DeviceOPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
MEDTRONIC ATS MEDICAL, INC.
3800 annapolis lane, suite 175
plymouth, MN 55447
PMA NumberP990046
Supplement NumberS034
Date Received07/01/2013
Decision Date07/30/2013
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR REVISING THE LIST OF POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE.
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