PMA P800049S007

Device
IRIDOCAPSULAR INTRAOCULAR LENS
Applicant
Alcon
PMA number
P800049
Supplement
S007
Product code
HQL
Decision date
1995-12-13
Generic name
intraocular lens
Approval order statement
APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME

Current openFDA PMA Record#

Device
IRIDOCAPSULAR INTRAOCULAR LENS
Applicant
Alcon
PMA number
P800049
Supplement
S007
Product code
HQL
Generic name
intraocular lens
Decision date
1995-12-13
Decision code
APPR
Date received
1995-08-09
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME