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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 700 INFLATABLE PENILE PROSTHESIS
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberN970012
Supplement NumberS094
Date Received11/20/2012
Decision Date02/06/2013
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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