PMA P880091

Device
SILICON UV-ABSORBING POSTERIOR CHAMBER IOL
Applicant
Staar Surgical Co.
PMA number
P880091
Supplement
S032
Product code
HQL
Decision date
2010-09-16
Generic name
intraocular lens
Approval order statement
APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.

Current openFDA PMA Record#

Device
SILICON UV-ABSORBING POSTERIOR CHAMBER IOL
Applicant
Staar Surgical Co.
PMA number
P880091
Supplement
S032
Product code
HQL
Generic name
intraocular lens
Decision date
2010-09-16
Decision code
APPR
Date received
2010-08-17
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.