PMA P950008S001

Device
SILIKON 1000
Applicant
Alcon
PMA number
P950008
Supplement
S001
Product code
LWL
Decision date
2000-07-11
Classification
Fluid, Intraocular
Generic name
Fluid, intraocular
Approval order statement
APPROVAL FOR A MODIFICATION TO THE MOLECULAR WEIGHT SPECIFICATION RANGE FROM 38,000-48,000 DALTONS TO 36,000-48,000 DALTONS.

Current openFDA PMA Record#

Device
SILIKON 1000
Applicant
Alcon
PMA number
P950008
Supplement
S001
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2000-07-11
Decision code
APPR
Date received
2000-06-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MODIFICATION TO THE MOLECULAR WEIGHT SPECIFICATION RANGE FROM 38,000-48,000 DALTONS TO 36,000-48,000 DALTONS.