PMA P010019S065

Device: Lotrafilcon A Soft Contact Lenses for Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S065
Product code: LPM
Decision date: 2018-05-22
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Expansion of front-end manufacturing capacity for lotrafolcon A lenses at the Alcon Malaysia production plant with an additional production line.

Current openFDA PMA Record#

Device: Lotrafilcon A Soft Contact Lenses for Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S065
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-05-22
Decision code: OK30
Date received: 2018-04-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Expansion of front-end manufacturing capacity for lotrafolcon A lenses at the Alcon Malaysia production plant with an additional production line.