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Food and Drug Administration

Circulatory System Devices Panel

September 19, 2007

BRIEFING INFORMATION

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.

REPEL-CV Bioresorbable Adhesion Barrier Film
P070005

2007-4318b1-01- FDA Executive Summary Section 1 (pdf)

2007-4318b1-02 -  Proposed Package Insert (pdf)

2007-4318b1-03 – SSED- Final (pdf)

2007-4318b1-04 – Study 4 (pdf)

Page last updated September 6, 2007 kkhorizonal rule
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