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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceAMS 700 INFLATABLE PENILE PROSTHESIS
Classification Nameprosthesis, penis, inflatable
Generic Nameprosthesis, penis, inflatable
Regulation Number876.3350
Applicant
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberN970012
Supplement NumberS089
Date Received09/28/2011
Decision Date10/26/2011
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the packaging process for the devices.
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