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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.
 
DeviceSALINE FILLED TESTICULAR PROSTHESIS
Classification Nameprosthesis, testicular
Generic Nameprosthesis, testicular
Regulation Number876.3750
Applicant
COLOPLAST CORP.
1601 west river road north
minneapolis, MN 55411
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 - manufacturer/sterilizer/packager/supplier
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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