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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 A/S
PMA NumberP000006
Supplement NumberS011
Date Received08/19/2008
Decision Date09/16/2008
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the ¿shelf life program for the titan inflatable penile prosthesis ¿ 60 degrees c accelerated and real time aging¿ (i. E. , shelf life testing protocol; document ¿mus 085:065¿), updated to incorporate the test parameters for the one-touch release (otr) pump.
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