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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 NameTITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Generic Nameinflatable penile prosthesis
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
PMA NumberP000006
Date Received01/18/2000
Decision Date07/14/2000
Product Code
FHW[ Registered Establishments with FHW ]
Docket Number 00M-1415
Notice Date 07/25/2000
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mentor alpha i inflatable penile prosthesis. This device is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 
S009 S010 S011 S012 S013 S014 
S015 S017 S018 S019 S021 S022 
S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 
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