PMA P120006S009

Device

OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Applicant

Endologix, LLC

PMA number

P120006

Supplement

S009

Product code

MIH

Decision date

2014-04-23

Classification

System, Endovascular Graft, Aortic Aneurysm Treatment

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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.