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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 | S003 |
Date Received | 10/17/2002 |
Decision Date | 07/14/2003 |
Product Code |
FHW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MARKETING CLAIMS REGARDING WATER ABSORPTION BY THE TITAN INFLATABLE PENILE PROSTHESIS. |
Post-Approval Study | Show Report Schedule and Study Progress |