PMA P890056S005

Device: MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P890056
Supplement: S005
Product code: HQL
Decision date: 1997-10-02
Generic name: intraocular lens
Approval order statement: Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico.

Current openFDA PMA Record#

Device: MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P890056
Supplement: S005
Product code: HQL
Generic name: intraocular lens
Decision date: 1997-10-02
Decision code: APPR
Date received: 1997-06-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico.