|
Device | SALINE-FILLED 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 | S003 |
Date Received | 07/13/2004 |
Decision Date | 07/28/2004 |
Product Code |
FAF |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A CAUTIONARY STATEMENT TO THE OUTER PACKAGING SPECIFYING THAT THE DEVICE SHOULD BE FILLED WITH SALINE PRIOR TO IMPLANTATION. |