PMA P940007

Device: CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Advanced Medical Optics, Inc.
PMA number: P940007
Supplement: S006
Product code: HQL
Decision date: 2001-04-02
Generic name: intraocular lens
Approval order statement: APPROVAL FOR STERILIZING THE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 912, AT THE FACILITY IN GRONINGEN, THE NETHERLAND AND FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS FOR MODEL 912 FROM 100% ETHYLENE OXIDE (ET0) TO 20 % ET0/80% CARBON DIOXIDE.

Current openFDA PMA Record#

Device: CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Advanced Medical Optics, Inc.
PMA number: P940007
Supplement: S006
Product code: HQL
Generic name: intraocular lens
Decision date: 2001-04-02
Decision code: APPR
Date received: 2000-09-05
Supplement type: Normal 180 Day Track
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR STERILIZING THE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 912, AT THE FACILITY IN GRONINGEN, THE NETHERLAND AND FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS FOR MODEL 912 FROM 100% ETHYLENE OXIDE (ET0) TO 20 % ET0/80% CARBON DIOXIDE.