TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT

FDA premarket approval P120006/S015 · decided 2015-02-02

Approval details

PMA number

P120006

Supplement

S015

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

Endologix, LLC

Date received

2014-08-07

Decision date

2015-02-02

Days to decision

179 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Santa Rosa, CA

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