|
Device | BARD TEGRESS URETHRAL IMPLANT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | C.R. Bard, Inc. 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 |
PMA Number | P030030 |
Supplement Number | S005 |
Date Received | 02/02/2007 |
Decision Date | 02/16/2007 |
Withdrawal Date
|
04/06/2007 |
Product Code |
LNM |
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 FOR CHANGES TO THE TEGRESS URETHRAL IMPLANT INSTRUCTIONS FOR USE AND PATIENT INFORMATION BROCHURE TO MINIMIZE THE INCIDENCE OF ADVERSE EVENTS (E.G., EROSION AND NECROSIS) AND ENHANCE THE SAFETY OF DEVICE USE. |