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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 Ascending Aortic Prosthesis
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP000037
Supplement NumberS051
Date Received07/05/2017
Decision Date12/14/2017
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional ethylene oxide sterilization site located at 1300 East Anderson Lane, Building B, Austin, Texas.
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