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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, Model Onxa
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP000037
Supplement NumberS052
Date Received09/20/2018
Decision Date10/18/2018
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of an inspection to verify suture orientation marks.
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