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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 NumberS002
Date Received06/12/2018
Decision Date07/12/2018
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  
Change to the manufacturer of the adhesion promoter used in the coating process of the COBRA PzF stent.
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