Pilkington Barnes Hind USA; Premarket Approval of Precision UVSUPTM (Vasurfilcon A) Hydrophilic Contact Lens for Extended Wear

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Pilkington Barnes Hind, USA, Sunnyvale, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Precision UV TM (vasurfilcon A) Hydrophilic Contact Lens for extended wear. The device is to be manufactured under an agreement with Allergan Medical Optics, Irvine, CA, which has authorized Pilkington Barnes Hind, USA to incorporate information contained in its approved premarket approval application (PMA) for the lidofilcon B nonultraviolet absorbing lens material and all related supplements that lead to the approval of the vasurfilcon A material. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 30, 1994, of the approval of the application.