PMA P840064S064

Device: OPHTHALMIC VICOSURGICAL DEVICE (OVD)
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S064
Product code: LZP
Decision date: 2017-10-25
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Approval for the use of Alcon Ireland Cork (AIC) as an alternative supplier of the cannula component to be used as part of the finished Ophthalmic Viscosurgical Devices (OVDs) at Alcon-Couvreur (Purrs) manufacturing facility.

Current openFDA PMA Record#

Device: OPHTHALMIC VICOSURGICAL DEVICE (OVD)
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S064
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2017-10-25
Decision code: APPR
Date received: 2017-02-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the use of Alcon Ireland Cork (AIC) as an alternative supplier of the cannula component to be used as part of the finished Ophthalmic Viscosurgical Devices (OVDs) at Alcon-Couvreur (Purrs) manufacturing facility.