|
Device | PROVISC OPHTHALMIC VISCOSURGICAL DEVICE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Alcon Research, Ltd. 6201 SOUTH FREEWAY, R3-48 FORT WORTH, TX 76134-2099 |
PMA Number | P890047 |
Supplement Number | S015 |
Date Received | 04/24/2003 |
Decision Date | 05/23/2003 |
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 ADDITION FOR THE FOLLOWING PRECAUTION TO THE PRODUCT INSERT: "USE ONLY IF THE CONTAINER IS UNDAMAGED." |