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Food and Drug Administration

Anesthesiology and Respiratory Therapy Devices Panel

June 12, 2008

BRIEFING INFORMATION

NeoMend

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 spaces on the screen or on the printed page.

Sponsors Executive Summary, NeoMend (pdf)

Sponsors Summary of Preclinical Data, NeoMend (pdf)

Sponsors Summary of Clinical Data, NeoMend (pdf)

Sponsors Key Prolonged Air Leak Following Radical Upper Lobectomy, NeoMend (pdf) (Copyrighted Material)

Sponsors Protocol, NeoMend (pdf)

Sponsors Summary of Safety and Effectiveness, NeoMend, (pdf)

Sponsors Instructions for Use, NeoMend, (pdf)

Sponsors Instructions for Use, NeoMend, (pdf)

FDA

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.

Executive Summary, FDA (pdf)

Page last updated June 9, 2008 kkhorizonal rule
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