Food and Drug Administration

Neurological Devices Panel of the Medical Devices Advisory Committee

August 5, 2003

Briefing Information

Microtherapeutics, Inc. PMA 030004, The Onyx(r) Liquid Embolic System

Food and Drug Administration

Clinical Review of MTI, Onyx(r) Liquid Embolization System (PDF) (HTM) (Word)

Statistical Review for PMA P030004, Onyx LES Liquid Embolic System, Micro Therapeutics, Inc. (PDF) (HTM) (Word)

Drug Review (PDF) (HTM) (Word)

Preclinical Review (PDF) (HTM) (Word)

Preclinical Review - Additional Information (PDF) (HTM) (Word)

Micro Therapeutics, Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Panel Pack (PDF) (HTM) (Word)