FDA.reportPublic FDA data

PMA P120006S041

Device
Alto Abdominal Stent Graft System
Applicant
Endologix, LLC
PMA number
P120006
Supplement
S041
Product code
MIH
Decision date
2022-12-22
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of a supplier change for the guide wire lumen component of the Ovation iX Iliac Limb Delivery Catheter and Ovation iX Iliac Extension Delivery Catheter.

Current openFDA PMA Record#

Device
Alto Abdominal Stent Graft System
Applicant
Endologix, LLC
PMA number
P120006
Supplement
S041
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2022-12-22
Decision code
OK30
Date received
2022-12-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a supplier change for the guide wire lumen component of the Ovation iX Iliac Limb Delivery Catheter and Ovation iX Iliac Extension Delivery Catheter.