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. |
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Device | MENTOR TITAN INFLATABLE PENILE PROSTHESIS |
Generic Name | Device, impotence, mechanical/hydraulic |
Regulation Number | 876.3350 |
Applicant | COLOPLAST CORP. 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 |
PMA Number | P000006 |
Supplement Number | S002 |
Date Received | 08/07/2002 |
Decision Date | 01/14/2003 |
Product Code |
FHW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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