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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.
 
Trade NameAMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)
Classification Nameprosthesis, penis, inflatable
Generic Namepenile inflatable implant
Regulation Number876.3350
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberN970012
Supplement NumberS085
Date Received11/26/2010
Decision Date12/22/2010
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to replace the sterilization monitoring device.
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