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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 NumberS007
Date Received02/15/2019
Decision Date02/20/2019
Withdrawal Date12/22/2022
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Move in-process inspections, move the location of the lot number label on the device, and change the lot number label process.
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