PMA P120006S008

Device: TRI VASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM; TRI VASCULAR, INC OVATION PRIME ABDOMINAL ABDOMINAL STENT GRAFT
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S008
Product code: MIH
Decision date: 2013-12-02
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN CAUTION STATEMENTS.

Current openFDA PMA Record#

Device: TRI VASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM; TRI VASCULAR, INC OVATION PRIME ABDOMINAL ABDOMINAL STENT GRAFT
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S008
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2013-12-02
Decision code: APPR
Date received: 2013-11-04
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN CAUTION STATEMENTS.