PMA P810032S054

Device
PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant
Alcon Laboratories
PMA number
P810032
Supplement
S054
Product code
HQL
Decision date
2009-07-23
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.

Current openFDA PMA Record#

Device
PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant
Alcon Laboratories
PMA number
P810032
Supplement
S054
Product code
HQL
Generic name
intraocular lens
Decision date
2009-07-23
Decision code
OK30
Date received
2009-06-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.