PMA P120006S001

Device

OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Applicant

Endologix, LLC

PMA number

P120006

Supplement

S001

Product code

MIH

Decision date

2012-12-11

Classification

System, Endovascular Graft, Aortic Aneurysm Treatment

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Approval order statement

APPROVAL FOR MODIFICATIONS TO THE ENDOVASCULAR SYSTEM, MAINLY THE DELIVERY SYSTEM, TO IMPROVE THE EASE-OF-USE DURING DEPLOYMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM AND 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, 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 DEGREE 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 B) WITH AN INNER WALL DIAMETER OF NO LESS THEN 8 MM AND NO GREATER THAN 20 MM.