PMA P110032S006

Device: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
Applicant: Lombard Medical Limited
PMA number: P110032
Supplement: S006
Product code: MIH
Decision date: 2013-11-21
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR REVISED INSTRUCTIONS FOR USE (IFU) TO ADD WARNINGS AND PRECAUTIONS BASED ON DATA FROM ONGOING FOLLOW-UP OF SUBJECTS IN THE IDE STUDY.

Current openFDA PMA Record#

Device: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
Applicant: Lombard Medical Limited
PMA number: P110032
Supplement: S006
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2013-11-21
Decision code: APPR
Date received: 2013-10-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISED INSTRUCTIONS FOR USE (IFU) TO ADD WARNINGS AND PRECAUTIONS BASED ON DATA FROM ONGOING FOLLOW-UP OF SUBJECTS IN THE IDE STUDY.