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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.
Classification Nameprosthesis, penis, inflatable
Generic Nameprosthesis, penis, inflatable
Regulation Number876.3350
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberN970012
Supplement NumberS094
Date Received11/20/2012
Decision Date02/06/2013
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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. Thedevices, as modified, will be marketed under the trade names:1) ams 700 and ambicor inflatable penile prosthesis (ipp) are intended for use in thetreatment 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 fecalincontinence in males and females eighteen years and older who have failed, or are notcandidates for, less invasive forms of restorative therapy.