Food and Drug Administration

Gastroenterology and Urology Devices Panel

January 17, 2003

Briefing Information

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.

Draft Issues for Discussion (PDF) (Word)

Summary of Safety and Effectiveness Data, Enteric Medical Technologies, Inc. (PDF) (Word)

Emteryx™ Procedure Kit for GERD-Instructions for Use (PDF) (Word)

Patient Information Brochure--Enteryx™ Procedure for the Treatment of Gastroesophageal Reflux Disease (GERD) (PDF) (Word)