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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES
Classification Nameprosthesis, penis, inflatable
Generic Namepenile inflatable implant
Regulation Number876.3350
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberN970012
Date Received12/22/1997
Decision Date11/02/1998
Product Code
JCW[ Registered Establishments with JCW ]
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ams 700 series inflatable penile prosthesis product line. This device is indicated for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Supplements: S083 S084 S085 S086 S087 S089 S094 S096 S097 
S098 S100 S101 
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