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U.S. Department of Health and Human Services

Advisory Committees

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Gastroenterology and Urology Devices Panel - August 17, 2001

On August 17, 2001, the Gastroenterology and Urology Devices Advisory Panel met to make recommendations on P010020, the AMS ActiconÔ Neosphincter from American Medical Systems (AMS) for the treatment of severe fecal incontinence. This device is an implantable silicone cuff, balloon, and pump that closes the rectum to maintain fecal continence. The Panel voted 7 to 1 in favor of a recommendation to approve the PMA with four conditions. The conditions outlined by the Panel were: (1) FDA should work with the sponsor to develop a training program; (2) the patient labeling should include tables of success versus failure, European data, and a statement that this device is an alternative to a stoma, and the physician labeling should include more data; (3) that the device not be available to post pubescent children under age 18, except through the HDE; (4) A post-market follow-up study for 1 year of patients including the explanted patients. The labeling should be updated with this information.

Contact: Jeffrey Cooper, D.V.M., Executive Secretary, 301-594-1220, x121

Transcripts may be purchased from: (Written Request Only)

 

Neal R. Gross & Company
1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005
202-234-4433

or

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice)/(301) 443-1726 (fax)

 

Executive Summary may be purchased from: (written request only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)