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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 SERIES INFATABLE 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 NumberS097
Date Received11/26/2013
Decision Date03/06/2014
Product Code
JCW[ Registered Establishments with 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 Product No
Approval Order Statement 
Approval for changes to manual inspection methods, addition of an alternate automated inspection method and redefinition of the diameter measurement region.
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