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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 Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 ROBERTS BLVD NW
KENNESAW, GA 30144
PMA NumberP000037
Supplement NumberS054
Date Received06/19/2019
Decision Date08/15/2019
Product Code LWQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT02677974
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the revised protocol for the Newly Enrolled On-X Post-Approval Study.
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