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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 NumberS018
Date Received05/20/2021
Decision Date10/12/2021
Withdrawal Date12/22/2022
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the updated final labeling to reflect the 5-year data obtained in the PzF SHIELD PAS study.
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