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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP000053
Supplement NumberS047
Date Received11/06/2012
Decision Date02/06/2013
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
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.
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