PMA P880031S014

Device: HEALON D
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S014
Product code: LZP
Decision date: 2008-08-22
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL TO MOVE THE MANUFACTURE OF VITRAX FROM THE ALLERGAN FACILITY IN WESTPORT, IRELAND TO THE AMO UPPSALA FACILITY IN SWEDEN, FOR A 0.4 ML FILL VOLUME IN ADDITION TO THE CURRENTLY APPROVED 0.65 ML FILL VOLUME, AND RE-BRAND THE DISPERSIVE VITRAX PRODUCT MANUFACTURED IN UPPSALA, SWEDEN AS HEALON D (DISPERSIVE).

Current openFDA PMA Record#

Device: HEALON D
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S014
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2008-08-22
Decision code: APPR
Date received: 2007-02-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MOVE THE MANUFACTURE OF VITRAX FROM THE ALLERGAN FACILITY IN WESTPORT, IRELAND TO THE AMO UPPSALA FACILITY IN SWEDEN, FOR A 0.4 ML FILL VOLUME IN ADDITION TO THE CURRENTLY APPROVED 0.65 ML FILL VOLUME, AND RE-BRAND THE DISPERSIVE VITRAX PRODUCT MANUFACTURED IN UPPSALA, SWEDEN AS HEALON D (DISPERSIVE).