PMA P150028S002

Device
NuDel Delivery System
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S002
Product code
PNF
Decision date
2018-11-14
Classification
Aortic Stent
Generic name
Aortic stent
Approval order statement
Approval for the NuDEL Delivery System.

Current openFDA PMA Record#

Device
NuDel Delivery System
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S002
Product code
PNF
Generic name
Aortic stent
Decision date
2018-11-14
Decision code
APPR
Date received
2018-03-07
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the NuDEL Delivery System.