|
Device | CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 South Freeway Fort Worth, TX 76134 |
PMA Number | P990023 |
Supplement Number | S003 |
Date Received | 05/14/2004 |
Decision Date | 05/26/2004 |
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 TO ADD SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE LABELING. |