PMA P840064S023

Device: VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S023
Product code: LZP
Decision date: 2002-03-25
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE. THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT.

Current openFDA PMA Record#

Device: VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S023
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2002-03-25
Decision code: APPR
Date received: 2002-02-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE. THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT.