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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 Dr. Suite 1500
San Antonio, TX 78230
PMA NumberP160014
Supplement NumberS009
Date Received04/16/2019
Decision Date12/24/2019
Withdrawal Date12/22/2022
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the labeling, including the maximum post-dilatation limits.
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