PMA P150028S004

Device
CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S004
Product code
PNF
Decision date
2019-12-19
Generic name
Aortic stent
Approval order statement
Addition of two laser welders.

Current openFDA PMA Record#

Device
CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL
Applicant
NuMED, Inc.
PMA number
P150028
Supplement
S004
Product code
PNF
Generic name
Aortic stent
Decision date
2019-12-19
Decision code
OK30
Date received
2019-11-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of two laser welders.