PMA P150028S005

Device
NuDEL Delivery System
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S005
Product code
PNF
Decision date
2021-07-28
Generic name
Aortic stent
Approval order statement
Approval to extend the packaging shelf life of the NuDEL Delivery System.

Current openFDA PMA Record#

Device
NuDEL Delivery System
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S005
Product code
PNF
Generic name
Aortic stent
Decision date
2021-07-28
Decision code
APPR
Date received
2021-04-28
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval to extend the packaging shelf life of the NuDEL Delivery System.