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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.
 
DeviceMENTOR SALINE-FILLED TESTICULAR PROSTHESIS
Generic NameProsthesis, testicular
Regulation Number876.3750
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP020003
Supplement NumberS001
Date Received11/07/2002
Decision Date02/05/2003
Product Code FAF 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISION OF THE POSTAPPROVAL STUDY PROTOCOL TO DISCONTINUE THE REQUIREMENT FOR BLOOD COLLECTION AT THE 5-YEAR EXAM.
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