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Device | VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S023 |
Date Received | 02/20/2002 |
Decision Date | 03/25/2002 |
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 | Yes |
Approval Order Statement APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE. THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT. |