PMA P010019S038

Device: LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S038
Product code: LPM
Decision date: 2015-05-05
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: CHANGING THE NACL ION PERMEABILITY TEST TO CORRECT FOR VARIABLE THICKNESS LENSES AND THE ASSOCIATED SOFTWARE UPDATE.

Current openFDA PMA Record#

Device: LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S038
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2015-05-05
Decision code: OK30
Date received: 2015-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGING THE NACL ION PERMEABILITY TEST TO CORRECT FOR VARIABLE THICKNESS LENSES AND THE ASSOCIATED SOFTWARE UPDATE.