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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.
 
DeviceSALINE FILLED TESTICULAR PROSTHESIS
Generic NameProsthesis, testicular
Regulation Number876.3750
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberP020003
Supplement NumberS006
Date Received11/24/2008
Decision Date12/22/2008
Product Code FAF 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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