Premarket Approval (PMA)

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.

• Device: TITAN INFLATABLE PENILE PROSTHESIS
• Generic Name: Device, impotence, mechanical/hydraulic
• Regulation Number: 876.3350
• Applicant: COLOPLAST CORP.; 1601 WEST RIVER ROAD NORTH; MINNEAPOLIS, MN 55411
• PMA Number: P000006
• Date Received: 01/18/2000
• Decision Date: 07/14/2000
• Product Code: FHW
• Docket Number: 00M-1415
• Notice Date: 07/25/2000
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• 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
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S037 S025 S026 S027 S022 S023 S024 S035 S033 S028 S045 ; S040 S041 S042 S043 S005 S001 S002 S003 S014 S021 S007 S034 ; S036 S029 S030 S031 S032 S044 S038 S039 S004 S011 S015 S009 ; S019 S012 S010 S017 S018 S047 S046 S013 S050 S056 S057 S058 ; S064 S065 S059 S049 S053 S054 S051 S052 S066 S063 S062 S061 ; S060 S067