|
Device | ONYX LIQUID EMBOLIC SYSTEM |
Generic Name | Agent, injectable, embolic |
Applicant | EV3 NEUROVASCULAR 9775 Toledo Way Irvine, CA 92618 |
PMA Number | P030004 |
Supplement Number | S003 |
Date Received | 09/24/2007 |
Decision Date | 10/09/2007 |
Product Code |
MFE |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |