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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
Classification Nameprosthesis, penis, inflatable
Generic Namepenile inflatable implant
Regulation Number876.3350
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberN970012
Supplement NumberS084
Date Received11/18/2010
Decision Date12/16/2010
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a warning statement in the ifu pertaining to the appropriate cleaning method of reusable tools used in the ams 700 and ambicor inflatable penile prostheses.
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