PMA P850057S005

Device: CUSTOMEYES(TM) 45L&55L (BUFILCON A)
Applicant: Ciba Vision Corporation
PMA number: P850057
Supplement: S005
Product code: LPM
Decision date: 1995-09-22
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES

Current openFDA PMA Record#

Device: CUSTOMEYES(TM) 45L&55L (BUFILCON A)
Applicant: Ciba Vision Corporation
PMA number: P850057
Supplement: S005
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1995-09-22
Decision code: APPR
Date received: 1995-05-15
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES