PMA P090022S002

Device: SOFTEC HD POSTERIOR CHAMBER INTROCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S002
Product code: HQL
Decision date: 2010-08-13
Generic name: intraocular lens
Approval order statement: APPROVAL TO AMEND THE APPROVED LABELING FOR THE SOFTEC HD IOL TO ALLOW FOR THE USE OF THE MEDICEL VISCOJECT 1.8, MODEL# LP604350 WITH THE SOFTEC HD AND SOFTEC I IOLS.

Current openFDA PMA Record#

Device: SOFTEC HD POSTERIOR CHAMBER INTROCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S002
Product code: HQL
Generic name: intraocular lens
Decision date: 2010-08-13
Decision code: APPR
Date received: 2010-07-02
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO AMEND THE APPROVED LABELING FOR THE SOFTEC HD IOL TO ALLOW FOR THE USE OF THE MEDICEL VISCOJECT 1.8, MODEL# LP604350 WITH THE SOFTEC HD AND SOFTEC I IOLS.