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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 NameTITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
PMA NumberP000006
Supplement NumberS024
Date Received05/02/2011
Decision Date02/13/2012
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) a change in the angle of the tubing on the cylinder from the current 45 degrees to 0 degrees angle to improve the ease of implantation; and 2) to change the tip material from dipped-on bioflex to bonded-on med 4750.
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