PMA P010019S078

Device: Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S078
Product code: LPM
Decision date: 2021-08-27
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for a manufacturing site located at CIBA VISION Asia Manufacturing and Logistics Pte Ltd., 133 Tuas South Avenue 3, Singapore 637550 Manufacturing Operation: Repackaging.

Current openFDA PMA Record#

Device: Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S078
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2021-08-27
Decision code: APPR
Date received: 2021-06-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at CIBA VISION Asia Manufacturing and Logistics Pte Ltd., 133 Tuas South Avenue 3, Singapore 637550 Manufacturing Operation: Repackaging.