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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
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
CELONOVA BIOSCIENCES, INC.
8023 vantage drive, suite 1500
san antonio, TX 78230
PMA NumberP160014
Supplement NumberS001
Date Received03/19/2018
Decision Date04/16/2018
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to an in-process inspection step in the manufacturing process for the COBRA PzF NanoCoated Coronary Stent System.
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