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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.
Classification Nameprosthesis, penis, inflatable
Generic Nameprosthesis, penis, inflatable
Regulation Number876.3350
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberN970012
Supplement NumberS096
Date Received07/16/2013
Decision Date08/14/2013
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications of the operating room manual by additional emphasis, instructions, and information for tube inflation/deflation issues in the troubleshooting, surgical, and post-operative procedure sub-sections.