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. |
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Device | AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS) |
Generic Name | Implanted fecal incontinence device |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P010020 |
Supplement Number | S027 |
Date Received | 11/13/2012 |
Decision Date | 02/06/2013 |
Withdrawal Date
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12/12/2016 |
Product Code |
MIP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-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. 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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