Biocompatibles, Inc.; Premarket Approval of Soft-55 EW Aphakic (vifilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Biocompatibles, Inc., Norfolk, VA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of Soft-55 EW Aphakic (vifilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear. The device is to be manufactured under an agreement with Ciba Vision Corp., Duluth, GA, which has authorized Biocompatibles, Inc., to incorporate information contained in its approved premarket approval applications (PMA's) for the Softcon E.W. (vifilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of April 17, 1997, of the approval of the application.