PMA P010019S050

Device: AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S050
Product code: LPM
Decision date: 2016-07-19
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for the addition of 0.04% (400ppm) polyoxyethylene-poluoxybutylene copolymer (EO45BO10) to the package saline for lotrafilcon B silicone hydrogel soft contact lenses for extended wear.

Current openFDA PMA Record#

Device: AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S050
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-07-19
Decision code: APPR
Date received: 2016-04-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of 0.04% (400ppm) polyoxyethylene-poluoxybutylene copolymer (EO45BO10) to the package saline for lotrafilcon B silicone hydrogel soft contact lenses for extended wear.