PMA P040002S043
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S043
- Product code
- MIH
- Decision date
- 2013-08-12
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL OF NEW PLATINUM/TUNGSTEN RADIOPAQUE COIL MARKERS TO BE ADDED CIRCUMFERENTIALLY IN THE PROXIMAL HEM OF THE SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORY STENT GRAFTS.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S043
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-08-12
- Decision code
- APPR
- Date received
- 2013-07-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF NEW PLATINUM/TUNGSTEN RADIOPAQUE COIL MARKERS TO BE ADDED CIRCUMFERENTIALLY IN THE PROXIMAL HEM OF THE SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORY STENT GRAFTS.