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 FDA’s 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