PMA P150028S006

Device
G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S006
Product code
PNF
Decision date
2021-12-13
Generic name
Aortic stent
Approval order statement
Approval for the G-Armor Stent Family and includes dimensional design modifications to the currently approved CP Stent Family.

Current openFDA PMA Record#

Device
G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S006
Product code
PNF
Generic name
Aortic stent
Decision date
2021-12-13
Decision code
APPR
Date received
2021-09-14
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the G-Armor Stent Family and includes dimensional design modifications to the currently approved CP Stent Family.