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Device | 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 | S040 |
Date Received | 01/27/2015 |
Decision Date | 04/13/2015 |
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 |
Approval Order Statement APPROVAL FOR CHANGES IN THE LABELING OF THE TITAN INFLATABLE PENILE PROSTHESIS SURGICAL PROTOCOL TO INCORPORATE ECTOPIC PLACEMENT. |