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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantLombard Medical Limited
4 Trident Park
Didcot OX11 7HJ
PMA NumberP110032
Supplement NumberS006
Date Received10/22/2013
Decision Date11/21/2013
Withdrawal Date03/13/2018
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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