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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOVATION ABDOMINAL STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403
PMA NumberP120006
Date Received04/11/2012
Decision Date10/05/2012
Product Code MIH 
Docket Number 12M-1110
Notice Date 11/08/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT01092117
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE OVATION ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINALAORTIC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL PROXIMAL AORTIC NECK: A) WITH A LENGTH OF AT LEAST 7 MM PROXIMAL TO THE ANEURYSM; B) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM; AND C) WITH AN AORTIC ANGLE OF <= 60 DEGREES IF PROXIMAL NECK IS >= 10 MM AND <=45 DEGREES IF PROXIMAL NECK IS <10 MM. 3) ADEQUATE DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM; AND WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 S026 
S028 S029 S030 S031 S032 S034 S035 S036 S037 S039 S041 S042 
S043 S044 
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