Food and Drug
Administration
Obstetrics and Gynecology Devices Panel
August 29, 2006
Briefing Information
FDA Executive Summary (pdf)
Mirabel Medical Systems, 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.
Expert Report (pdf)
T-Scan 2000 ED, PMA P050003 Panel Pack (pdf)