COBRA PzF NanoCoated Coronary Stent System

FDA Premarket Approval P160014 S016

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.

Pre-market Approval Supplement Details

Minor change to the manufacturing of a packaging component.

DeviceCOBRA PzF NanoCoated Coronary Stent System
Generic NameStent, Coronary
ApplicantCELONOVA BIOSCIENCES, INC.
Date Received2020-04-21
Decision Date2020-04-27
PMAP160014
SupplementS016
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CELONOVA BIOSCIENCES, INC. 8023 Vantage Drive, Suite 1500 san Antonio, TX 78230

Supplemental Filings

Supplement NumberDateSupplement Type
P160014Original Filing
S016 2020-04-21 30-day Notice
S015
S014 2019-09-12 30-day Notice
S013
S012
S011
S010
S009
S008 2019-02-22 30-day Notice
S007 2019-02-15 30-day Notice
S006 2018-10-23 135 Review Track For 30-day Notice
S005 2018-10-19 Real-time Process
S004 2018-09-04 30-day Notice
S003 2018-08-16 Real-time Process
S002 2018-06-12 30-day Notice
S001 2018-03-19 30-day Notice

NIH GUDID Devices

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