PMA P960034S002

Device: CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS
Applicant: Abbott Medical Optics, Inc.
PMA number: P960034
Supplement: S002
Product code: HQL
Decision date: 2007-05-08
Generic name: intraocular lens
Approval order statement: ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.

Current openFDA PMA Record#

Device: CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS
Applicant: Abbott Medical Optics, Inc.
PMA number: P960034
Supplement: S002
Product code: HQL
Generic name: intraocular lens
Decision date: 2007-05-08
Decision code: OK30
Date received: 2007-04-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.