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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.
 
DeviceCOBRA PzF NanoCoated Coronary Stent System
Generic NameSTENT, CORONARY
ApplicantCELONOVA BIOSCIENCES, INC.
8023 Vantage Drive, Suite 1500
San Antonio, TX 78230
PMA NumberP160014
Supplement NumberS005
Date Received10/19/2018
Decision Date01/17/2019
Withdrawal Date 12/22/2022
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the device packaging.
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