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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS)
Classification Nameimplanted fecal incontinence device
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP010020
Supplement NumberS027
Date Received11/20/2012
Decision Date02/06/2013
Product Code
MIP[ Registered Establishments with MIP ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the labeling change from 1. 5 tesla (1. 5t) magnetic resonance imaging (mri) strength level to 3. 0 tesla (3. 0t) for the bundled ams products. The devices, as modified, will be marketed under the trade names: 1) ams 700 and ambicor inflatable penile prosthesis (ipp) are intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence); 2) ams 800 artificial urinary sphincter (aus) treats urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery; and 3) ams acticon neosphincter, artificial bowel sphincter (abs) is to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of restorative therapy.
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