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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMENTOR SALINE-FILLED TESTICULAR PROSTHESIS
Classification Nameprosthesis, testicular
Generic Nametesticular prosthesis
Regulation Number876.3750
ApplicantMENTOR CORP.
PMA NumberP020003
Supplement NumberS001
Date Received11/07/2002
Decision Date02/05/2003
Product Code
FAF[ Registered Establishments with FAF ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
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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