FDA.reportPublic FDA data

PMA P030004S009

Device
ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR
Applicant
Ev3 Neurovascular
PMA number
P030004
Supplement
S009
Product code
MFE
Decision date
2015-12-18
Classification
Agent, Injectable, Embolic
Generic name
Agent, injectable, embolic
Approval order statement
THE ADDITION OF CLARIFICATION TO THE COATING PROCEDURE REGARDING THE TOP COAT CURING TIME AND THE INCLUSION OF AN ADDITIONAL WEIGHING BALANCE TO THE COATING PREPARATION PROCEDURE FOR THE APOLLO ONYX DELIVERY MICRO CATHETER.

Current openFDA PMA Record#

Device
ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR
Applicant
Ev3 Neurovascular
PMA number
P030004
Supplement
S009
Product code
MFE
Generic name
Agent, injectable, embolic
Decision date
2015-12-18
Decision code
OK30
Date received
2015-11-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
THE ADDITION OF CLARIFICATION TO THE COATING PROCEDURE REGARDING THE TOP COAT CURING TIME AND THE INCLUSION OF AN ADDITIONAL WEIGHING BALANCE TO THE COATING PREPARATION PROCEDURE FOR THE APOLLO ONYX DELIVERY MICRO CATHETER.