Up | AC Home Page

Gastroenterology and Urology Devices Panel

June 25, 2008

BRIEFING INFORMATION

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.

FDA Executive Summary (pdf)

PMA Voting Options (htm)

Sponsor

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.

Sponsor Summary
Part I (pdf)
Part II (pdf)

References and Guidelines

Study Protocols
Study 101.1 (pdf)
Study 102.1 (pdf)

Post Approval Study Synopsis (pdf)

Proposed Summary of Safety and Effectiveness Data (pdf)

Proposed Labeling
Proposed Physician Labeling (pdf)
Proposed Patient Labeling (pdf)
Proposed Package Insert (pdf)

---