PMA P160014S005

Device
COBRA PzF NanoCoated Coronary Stent System
Applicant
Celonova Biosciences, Inc.
PMA number
P160014
Supplement
S005
Product code
MAF
Decision date
2019-01-17
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
Approval for a change to the device packaging.

Current openFDA PMA Record#

Device
COBRA PzF NanoCoated Coronary Stent System
Applicant
Celonova Biosciences, Inc.
PMA number
P160014
Supplement
S005
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2019-01-17
Decision code
APPR
Date received
2018-10-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the device packaging.