|
Device | AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Lombard Medical Limited 4 Trident Park Didcot OX11 |
PMA Number | P110032 |
Supplement Number | S006 |
Date Received | 10/22/2013 |
Decision Date | 11/21/2013 |
Withdrawal Date
|
03/13/2018 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |