|
Device | CELLUGEL OPHTHALMIC VISCOSURGICAL |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 South Freeway Fort Worth, TX 76134 |
PMA Number | P990023 |
Supplement Number | S002 |
Date Received | 10/24/2003 |
Decision Date | 11/14/2003 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
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 ADDING THE PRECAUTION, "USE ONLY IF THE CONTAINER IS UNDAMAGED". |