PMA P090022S005

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S005
Product code: HQL
Decision date: 2011-09-22
Generic name: intraocular lens
Approval order statement: APPROVAL TO AMEND THE APPROVED LABELING TO ALLOW FOR THE USE OF THE ASICO SOFTIP INJECTION SYSTEM, MODEL NUMBER AS-9300 WITH THE SOFTEC HD, SOFTEC I AND SOFTEC HD PS INTRAOCULAR LENSES (IOLS).

Current openFDA PMA Record#

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S005
Product code: HQL
Generic name: intraocular lens
Decision date: 2011-09-22
Decision code: APPR
Date received: 2011-07-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO AMEND THE APPROVED LABELING TO ALLOW FOR THE USE OF THE ASICO SOFTIP INJECTION SYSTEM, MODEL NUMBER AS-9300 WITH THE SOFTEC HD, SOFTEC I AND SOFTEC HD PS INTRAOCULAR LENSES (IOLS).