PMA P950008S010

Device
SILIKON 1000
Applicant
Alcon
PMA number
P950008
Supplement
S010
Product code
LWL
Decision date
2013-07-15
Classification
Fluid, Intraocular
Generic name
Fluid, intraocular
Approval order statement
APPROVAL FOR LABELING MODIFICATIONS TO THE SILIKON 1000 OIL DIRECTIONS FOR USE.

Current openFDA PMA Record#

Device
SILIKON 1000
Applicant
Alcon
PMA number
P950008
Supplement
S010
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2013-07-15
Decision code
APPR
Date received
2013-06-11
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR LABELING MODIFICATIONS TO THE SILIKON 1000 OIL DIRECTIONS FOR USE.