PMA P030004S003

Device: ONYX LIQUID EMBOLIC SYSTEM
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S003
Product code: MFE
Decision date: 2007-10-09
Classification: Agent, Injectable, Embolic
Generic name: Agent, injectable, embolic
Approval order statement: APPROVAL FOR REVISION OF THE PRODUCT LABEL TO INCLUDE A BOXED WARNING REGARDING THE EMISSION OF SPARKS THAT OCCURS WHEN ONYX-EMBOLIZED TISSUE IS SURGICALLY RESECTED WITH MONOPOLAR ELECTROCAUTERY DEVICES.

Current openFDA PMA Record#

Device: ONYX LIQUID EMBOLIC SYSTEM
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S003
Product code: MFE
Generic name: Agent, injectable, embolic
Decision date: 2007-10-09
Decision code: APPR
Date received: 2007-09-24
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISION OF THE PRODUCT LABEL TO INCLUDE A BOXED WARNING REGARDING THE EMISSION OF SPARKS THAT OCCURS WHEN ONYX-EMBOLIZED TISSUE IS SURGICALLY RESECTED WITH MONOPOLAR ELECTROCAUTERY DEVICES.