TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

FDA premarket approval P120006/S007 · decided 2013-12-13

Approval details

PMA number

P120006

Supplement

S007

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

Endologix, LLC

Date received

2013-10-23

Decision date

2013-12-13

Days to decision

51 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Santa Rosa, CA

Statement

APPROVAL FOR MODIFICATIONS TO THE STOPCOCK VALUE, WHICH IS BEING REPLACED BY THE CALIFORNIA VALVE, AND THE NEW SUPPLIER FOR THE VALVE. 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) N