PMA P840064S039

Device: VISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S039
Product code: LZP
Decision date: 2008-12-23
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: USE OF ELECTRONIC BATCH RECORDING OF BUFFERING/ COMPOUNDING, FILL ORDERS AND STERILIZATION OF REACTORS/VESSELS FOR THE ALCON OPHTHALMIC VISCOSURGICAL DEVICES.

Current openFDA PMA Record#

Device: VISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S039
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2008-12-23
Decision code: OK30
Date received: 2008-11-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF ELECTRONIC BATCH RECORDING OF BUFFERING/ COMPOUNDING, FILL ORDERS AND STERILIZATION OF REACTORS/VESSELS FOR THE ALCON OPHTHALMIC VISCOSURGICAL DEVICES.