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Dockets Management

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Food and Drug Administration

Anesthesiology and Respiratory Devices Panel

December 5, 2008




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.

Executive Summary (pdf)

Questions (pdf)

Voting Options (pdf)



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 spaces on the screen or on the printed page.

Sponsors Executive Summary (pdf)

Clinical Study Protocol (pdf)

Statistical Analysis Plan (pdf)

Clinical Summary (pdf)

Clinical Study Report: Pages 1-100 (pdf), Pages 101-77 (pdf)

Summary of Safety and Effectiveness (pdf)

Instructions for Use (pdf)

Post Approval Study Proposals (pdf)

Page last updated December 2, 2008 kkhorizonal rule
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