January 20, 2004


Dear Panel Member:


Please review the information in this package in preparation for the February 23, 2004 Neurological Devices Panel meeting. This cover letter provides an index of the contents of this package. You will find one binder containing FDAs reviews and information provided by the sponsor. The binder contains the following:


Tab 1 Device Review

Tab 2 Clinical Review

Tab 3 Statistics Review

Tab 4 FDA Questions

Tab 5 510(k) Document (provided by the sponsor)


Because this application is a 510(k) and not a PMA, there will be no vote on recommendation of its clearance. The meeting will revolve around discussion of the questions in Tab 4. We appreciate your valuable input.

If you have any questions please do not hesitate to call (301-594-3090 x 207) or email (RPF@CDRH.FDA.GOV) me. We look forward to working with you.







Richard P. Felten

Lead Reviewer

General Surgery Devices Branch