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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 INFLATABLE PENILE PROSTHESIS
Classification Nameprosthesis, penis, inflatable
Generic Namepenile inflatable implant
Regulation Number876.3350
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberN970012
Supplement NumberS083
Date Received11/17/2010
Decision Date05/07/2012
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the material formulation and specifications of the suture-tie connectors.
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