COBRA PzF NanoCoated Coronary Stent System

FDA premarket approval P160014 · Stent, Coronary

PMA numberP160014

Approval

Applicant
Celonova Biosciences, Inc.
Received
May 2, 2016
Decision date
February 21, 2017 (APWD)
Supplements
18, latest October 12, 2021
Product code
MAF – Stent, Coronary

Official FDA PMA record

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.