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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 TITAN INFLATABLE PENILE PROSTHESIS
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberP000006
Supplement NumberS002
Date Received08/07/2002
Decision Date01/14/2003
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REPROCESSING FINAL, STERILIZED ALPHA I INFLATABLE PENILE PROSTHESES TO INCORPORATE THE HYDROPHILIC COATING THAT WAS PREVIOUSLY APPROVED FOR USE ON NEWLY MANUFACTURED PROSTHESES IN SUPPLEMENT 1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR TITAN INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
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