PMA P810055S067

Device: MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P810055
Supplement: S067
Product code: HQL
Decision date: 1997-05-28
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL 777A. THIS INTRAOCULAR LENS IS INDICATED FOR USE IN THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE AND OLDER, WHO ARE UNDERGOING A PRIMARY LENS IMPLANTATION, IN EITHER THE CILIARY SULCUS OR CAPSULAR BAG FOLLOWING AN EXTRACAPSULAR CATARACT EXTRACTION.

Current openFDA PMA Record#

Device: MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P810055
Supplement: S067
Product code: HQL
Generic name: intraocular lens
Decision date: 1997-05-28
Decision code: APPR
Date received: 1997-03-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL 777A. THIS INTRAOCULAR LENS IS INDICATED FOR USE IN THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE AND OLDER, WHO ARE UNDERGOING A PRIMARY LENS IMPLANTATION, IN EITHER THE CILIARY SULCUS OR CAPSULAR BAG FOLLOWING AN EXTRACAPSULAR CATARACT EXTRACTION.