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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.
 
DeviceOVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403
PMA NumberP120006
Supplement NumberS009
Date Received11/12/2013
Decision Date04/23/2014
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT01092117
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE INDICATION FOR USE FOR THE OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS BY CLARIFYING THAT PERCUTANEOUS ACCESS AND FEMORAL CUTDOWN ARE APPROPRIATE VASCULAR ACCESS TECHNIQUES. THE DEVICE, THE TRIVASCULAR OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORAL CUTDOWN OR PERCUTANEOUS), DEVICES, AND/OR ACCESSORIES; 2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13 MM BELOW THE INFERIOR RENAL ARTERY; AND B) WITH AN AORTIC ANGLE OF =< 60 DEGREES IF PROXIMAL NECK IS => 10 MM AND =<45 DEGREES IF PROXIMAL NECK IS <10 MM; AND 3) DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM; ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 MM.
Post-Approval StudyShow Report Schedule and Study Progress
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