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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.
 
DeviceTOROSA 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 NumberS007
Date Received08/18/2010
Decision Date11/10/2010
Product Code
FAF[ Registered Establishments with FAF ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change of the saline filled testicular prosthesis and the re-branding to ¿torosa testicular prosthesis¿.
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