PMA P810055S068

Device: MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P810055
Supplement: S068
Product code: HQL
Decision date: 1997-10-22
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval to extend the dioptric power range of Model 812B to -10D to +40D. The device 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: S068
Product code: HQL
Generic name: intraocular lens
Decision date: 1997-10-22
Decision code: APPR
Date received: 1997-05-14
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to extend the dioptric power range of Model 812B to -10D to +40D. The device 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.