|
Device | COLOPLAST SALINE-FILLED TESTICULAR IMPLANT |
Generic Name | Prosthesis, testicular |
Regulation Number | 876.3750 |
Applicant | COLOPLAST CORP. 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 |
PMA Number | P020003 |
Supplement Number | S005 |
Date Received | 07/23/2007 |
Decision Date | 10/09/2007 |
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 LABELING CHANGES TO REPORT POST APPROVAL STUDY RESULTS. |