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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
Applicant MEDTRONIC INC.
PMA NumberP990046
Supplement NumberS035
Date Received07/08/2013
Decision Date08/07/2013
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Review of: 1) installation qualification (iq) reports for 4 pieces of equipment related to an already approved site change supplement; and 2) one process qualification (pq) report for one piece of equipment related to an already approved site change supplement. These changes apply to the open pivot heart valve and open pivot aortic valved graft.
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