PMA P040002S033

Device
AFX ACCESSORY STENT GRAFT DELIVERY SYSTEMS
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S033
Product code
MIH
Decision date
2011-09-29
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
AUTOMATION OF A LOADING PROCESS.

Current openFDA PMA Record#

Device
AFX ACCESSORY STENT GRAFT DELIVERY SYSTEMS
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S033
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2011-09-29
Decision code
OK30
Date received
2011-08-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
AUTOMATION OF A LOADING PROCESS.