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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTITAN INFLATABLE PENILE PROSTHESIS
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberP000006
Date Received01/18/2000
Decision Date07/14/2000
Product Code FHW 
Docket Number 00M-1415
Notice Date 07/25/2000
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S045 S046 S047 S049 S050 S051 S052 
S053 S054 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 
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