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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 700 Inflatable Penile Prosthesis
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS163
Date Received05/23/2019
Decision Date02/13/2020
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of an improved UPLC method for release and stability, minor updates to microbial Zone of Inhibition method and other associated updates to the Sub System and System level Product Specifications for the AMS 700 Inflatable Penile Prosthesis with InhibiZone and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment to bring to current standards.
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