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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 Name TITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST MANUFACTURING US, LLC
PMA NumberP000006
Supplement NumberS017
Date Received05/12/2010
Decision Date07/02/2010
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new device production mold that incorporates a tear trim and strain relief feature, as well as modifications to associated engineering drawings and dimensional tolerance specifications.
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