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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameprosthesis, testicular
Generic Nameprosthesis, testicular
Regulation Number876.3750
1601 west river road north
minneapolis, MN 55411
PMA NumberP020003
Date Received01/22/2002
Decision Date07/19/2002
Product Code
FAF[ Registered Establishments with FAF ]
Docket Number 02M-0322
Notice Date 08/06/2002
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007