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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 NameCOLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Generic Nameinflatable penile prosthesis
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
PMA NumberP000006
Supplement NumberS007
Date Received08/21/2006
Decision Date06/13/2008
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: 1) revision of the current titan prosthesis to include a new one-touch release pump body; 2) addition of nusil technology med-4755 silicone as an optional alternative to the currently used nusil technology med-4515 and med-4750 silicones; 3) addition of a 1. 5cm rear tip extender in the titan assembly kits; 4) addition of a specification imposing a lower limit of 2. 5 lb for tactile force for deflation using the otr pump; and 5) labeling revisions relating to the above device changes. The device, as modified, will be marketed under the trade name titan otr inflatable penile prosthesis and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
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