PMA P840064S057

Device: VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S057
Product code: LZP
Decision date: 2014-10-29
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: ALTERNATE CONTRACT ETHYLENE OXIDE STERILIZATION VENDOR FOR PROVISC®, VISCOAT®, DUOVISC®, AND DISCOVISC® OPHTHALMIC VISCOSURGICAL DEVICES.

Current openFDA PMA Record#

Device: VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S057
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2014-10-29
Decision code: OK30
Date received: 2014-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE CONTRACT ETHYLENE OXIDE STERILIZATION VENDOR FOR PROVISC®, VISCOAT®, DUOVISC®, AND DISCOVISC® OPHTHALMIC VISCOSURGICAL DEVICES.