Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP000053
Supplement NumberS053
Date Received11/03/2014
Decision Date01/28/2015
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF (I) THE ZONE OF INHIBITION (ZOI) AS THE SHELF LIFE INDICATION FACTOR AND TO CONSISTENTLY USE (II) A TWO YEAR SHELF LIFE FOR INHIBIZONE® (IZ) TREATED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMS 800 ARTIFICIAL URINARY SPHINCTER (AMS 800). THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY. THE AMS 700 INFLATABLE PENILE PROSTHESIS (AMS 700) IS USED IN THE TREATMENT OF CHRONIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE).
-
-