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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 NameSALINE FILLED TESTICULAR PROSTHESIS
Classification Nameprosthesis, testicular
Generic Nametesticular prosthesis
Regulation Number876.3750
ApplicantCOLOPLAST CORP.
PMA NumberP020003
Supplement NumberS006
Date Received11/24/2008
Decision Date12/22/2008
Product Code
FAF[ Registered Establishments with FAF ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of a new method for marking the saline filled testicular prosthesis and the titan inflatable penile prosthesis and for boring suture holes on the titan inflatable penile prosthesis.
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