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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 NumberS010
Date Received05/31/2019
Decision Date03/29/2020
Withdrawal Date12/22/2022
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for moving finished good testing from post-sterilization to pre-sterilization and implementing new ultraviolet cure equipment for the delivery catheter.
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