|Approval Order Statement |
Approval for the labeling change from 1. 5 tesla (1. 5t) magneticresonance 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 toreduced 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 notcandidates for, less invasive forms of restorative therapy.