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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.
 
DeviceTRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403
PMA NumberP120006
Supplement NumberS015
Date Received08/07/2014
Decision Date02/02/2015
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL THE TO ADD A LARGER DIAMETER ILIAC LIMB AND ILIAC EXTENSION, A LONGERLENGTH ILIAC LIMB, AND DECREASE THE DELIVERY SYSTEM PROFILE FOR EACH ILIAC LIMB AND ILIAC EXTENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIMEABDOMINAL STENT GRAFT SYSTEM WITH THE OVATION IX ILIAC STENT GRAFT AND IS INDICATED FOR THETREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLEFOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATEILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORALCUTDOWN 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 13MM BELOW THE INFERIOR RENAL ARTERY, AND B) WITH AN AORTIC ANGLE OF < 60 DEGREES IF PROXIMAL NECK IS 10 ¿ MM 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 25 MM.
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