PMA P010019S036

Device: LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR, O2 OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM,AIR OPTIX AQUA
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S036
Product code: LPM
Decision date: 2013-12-05
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: TRANSITION FROM A SEMI-AUTOMATED TO A FULLY AUTOMATEDMANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR, O2 OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM,AIR OPTIX AQUA
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S036
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2013-12-05
Decision code: OK30
Date received: 2013-11-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: TRANSITION FROM A SEMI-AUTOMATED TO A FULLY AUTOMATEDMANUFACTURING PROCESS.