|
Device | TOROSA TESTICULAR PROSTHESIS |
Generic Name | Prosthesis, testicular |
Regulation Number | 876.3750 |
Applicant | COLOPLAST CORP. 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 |
PMA Number | P020003 |
Supplement Number | S007 |
Date Received | 08/18/2010 |
Decision Date | 11/10/2010 |
Product Code |
FAF |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE OF THE SALINE FILLED TESTICULAR PROSTHESIS AND THE RE-BRANDING TO ¿TOROSA TESTICULAR PROSTHESIS¿. |