Food and
Drug Administration
Orthopaedic
and Rehabilitation Devices Panel
July 17, 2007
BRIEFING
INFORMATION
Medtronic
Sofamor Danek BRYAN Cervical Disc P060023
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.
Proposed SSED (pdf)
Proposed Surgical Techniques (pdf)
Proposed Package Insert (pdf)
Proposed Patient Labeling (pdf)
Clinical Study Report (pdf)
Interim Analysis Tables (the entire file has been "Redacted")
Device Description (pdf)
Proposed Post-Approval Study (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)
