PMA P840064S060

Device: VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S060
Product code: LZP
Decision date: 2015-06-02
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD).

Current openFDA PMA Record#

Device: VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S060
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2015-06-02
Decision code: OK30
Date received: 2015-05-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD).