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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 and On-X Ascending Aortic Prosthesis devices
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP000037
Supplement NumberS057
Date Received12/07/2020
Decision Date03/04/2021
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the polyester fiber in the suture component.
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