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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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
Date Received05/02/2016
Decision Date02/21/2017
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 17M-1122
Notice Date 02/17/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01925794
NCT02224235
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to do novo lesions in native coronary arteries. The COBRA PzF Stent System is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.5-4.0 mm and lesion length of <24 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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