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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.
 
DeviceCOLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
Generic NameProsthesis, testicular
Regulation Number876.3750
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP020003
Supplement NumberS004
Date Received05/18/2006
Decision Date08/23/2006
Product Code FAF 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD BLACK INK TO IMPROVE THE VISIBILITY OF THE SERIAL NUMBERS.
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