Food and Drug
Administration
Orthopaedic and Regabilitation Devices Panel Meeting
September 19, 2006
Medtronic Sofamor Danek
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.
Device Description (pdf)
Clinical Study Report and Tables (pdf)
Proposed Summary of Safety and Effectiveness Data (pdf)
Proposed Surgical Technique (pdf)
Proposed Package Insert (pdf)
Proposed Patient Brochure (pdf)
FDA
Disclaimer
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the
FOIA) (5 U.S.C. §552). These redacted portions will appear
as white space on the screen or on the printed page.
FDA Executive Summary (pdf)
PMA Voting Options (pdf)