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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
Recalls CDRH Recalls
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
Post-Approval StudyShow Report Schedule and Study Progress
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 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 
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