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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.
 
DeviceON-X PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
On-X Life Technologies, Inc.
1655 roberts blvd nw
kennesaw, GA 30144
PMA NumberP000037
Supplement NumberS030
Date Received10/23/2012
Decision Date04/01/2015
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00291525
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A LABELING CHANGE TO ALLOW AORTIC VALVE REPLACEMENT PATIENTS TO BE TREATED USING A LOWERED ANTICOAGULATION TARGET.
Post-Approval StudyShow Report Schedule and Study Progress
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