Allergan Medical Optics; Premarket Approval of the Model PC-28LB Ultraviolet-Absorbing Posterior Chamber Intraocular Lens

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Allergan Medical Optics, Irvine, CA, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the Model PC-28LB ultraviolet-absorbing posterior chamber intraocular lens. After reviewing the recommendation of the Ophthalmic Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of May 26, 1994, of the approval of the application.