PMA P880031S013

Device: AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S013
Product code: LZP
Decision date: 1999-11-08
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Approval to 1) extend the finished product UV absorbance specification from 0.012 AU to 0.016 AU and 2) eliminate the UV absorbance specification from the 24 month shelf-life.

Current openFDA PMA Record#

Device: AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S013
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1999-11-08
Decision code: APPR
Date received: 1999-10-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to 1) extend the finished product UV absorbance specification from 0.012 AU to 0.016 AU and 2) eliminate the UV absorbance specification from the 24 month shelf-life.