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Dockets Management

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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)


Page last updated July 13, 2007 kkhorizonal rule
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