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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, AMS 800™ Artificial Urinary Sphincter with InhibiZone™
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP000053
Supplement NumberS124
Date Received03/15/2022
Decision Date04/01/2022
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Process change to the water bath monitoring requirements for assembly of the AMS 700 and AMS 800.
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