PMA P010019S053

Device: LOTRAFILCON A & B SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S053
Product code: LPM
Decision date: 2017-10-17
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for elimination of duplicate, redundant in process QC testing of raw materials used in the production of Alcon lotrafilcon A and B soft contact lens products for daily and extended wear.

Current openFDA PMA Record#

Device: LOTRAFILCON A & B SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S053
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-10-17
Decision code: APPR
Date received: 2017-01-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for elimination of duplicate, redundant in process QC testing of raw materials used in the production of Alcon lotrafilcon A and B soft contact lens products for daily and extended wear.