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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 (IPP) WITH INHIBIZONE
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS117
Date Received07/05/2016
Decision Date08/03/2016
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Quality control changes related to InhibiZone formulation including reduction of test samples, change in detection method from HPLC to UPLC, and change in facility conducting test.
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