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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTOROSA TESTICULAR PROSTHESIS
Generic NameProsthesis, testicular
Regulation Number876.3750
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP020003
Supplement NumberS007
Date Received08/18/2010
Decision Date11/10/2010
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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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