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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 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS174
Date Received01/23/2020
Decision Date02/21/2020
Product Code JCW 
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  
Automated removal of reservoir shells from the mold in the liquid injection molding (LIM) manufacturing process and to update the process parameter settings for the reservoir component of the AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone treatment.
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