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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 NameMENTOR TITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Generic Nameinflatable penile prosthesis
Regulation Number876.3350
ApplicantMENTOR CORP.
PMA NumberP000006
Supplement NumberS002
Date Received08/07/2002
Decision Date01/14/2003
Product Code
FHW[ Registered Establishments with FHW ]
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 reprocessing final, sterilized alpha i inflatable penile prostheses to incorporate the hydrophilic coating that was previously approved for use on newly manufactured prostheses in supplement 1. The device, as modified, will be marketed under the trade name mentor titan inflatable penile prosthesis and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered candidates for implantation of a penile prosthesis.
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