PMA P010019S068

Device: Lotrafilcon A and Lotrafilcon B Soft Contact Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S068
Product code: LPM
Decision date: 2018-08-28
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of parametric release as an alternate sterile product batch release option for Alcon Lotrafilcon A and B soft contact lenses.

Current openFDA PMA Record#

Device: Lotrafilcon A and Lotrafilcon B Soft Contact Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S068
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-08-28
Decision code: OK30
Date received: 2018-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of parametric release as an alternate sterile product batch release option for Alcon Lotrafilcon A and B soft contact lenses.