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Device | VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S060 |
Date Received | 05/13/2015 |
Decision Date | 06/02/2015 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD). |