PMA P100040S041

Device
Valiant Navion Thoracic Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100040
Supplement
S041
Product code
MIH
Decision date
2020-10-05
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for site change for packaging and labeling rework processes.

Current openFDA PMA Record#

Device
Valiant Navion Thoracic Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100040
Supplement
S041
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-10-05
Decision code
APPR
Date received
2020-09-04
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for site change for packaging and labeling rework processes.