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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 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP000053
Supplement NumberS113
Date Received05/18/2020
Decision Date06/16/2020
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  
Add a new lid printing machine for the AMS 700 Inflatable Penile Prosthesis (IPP), Ambicor IPP, and AMS 800 AUS (Urinary Control System).
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