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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
Generic Nameprosthesis, testicular
Regulation Number876.3750
ApplicantCOLOPLAST CORP.
1601 west river road north
minneapolis, MN 55411
PMA NumberP020003
Date Received01/22/2002
Decision Date07/19/2002
Product Code FAF 
Docket Number 02M-0322
Notice Date 08/06/2002
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MENTOR SALINE-FILLED TESTICULAR PROSTHESIS. THE DEVICE IS INDICATED FOR USE WHEN COSMETIC TESTICULAR REPLACEMENT IS INDICATED; I.E., IN THE CASE OF AGENESIS OR FOLLOWING THE SURGICAL REMOVAL OF A TESTICLE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
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