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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 (with InhibiZone)
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS202
Date Received03/29/2024
Decision Date05/23/2024
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change to the batch release and stability evaluation for AMS 700™ Inflatable Penile Prosthesis and AMS 800™ Artificial Urinary Sphincter with lnhibiZone products
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