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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) with and without lnhibiZone
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP000053
Supplement NumberS137
Date Received03/07/2025
Decision Date06/03/2025
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to the AMS 800 product packaging artwork, product labels, eLabeling Access Statement Insert, Physician Instructions for Use, Magnetic Resonance Imaging (MRI) Safety Information to support the MR Conditional labeling, and Patient Guide
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