PMA P950008S003

Device
SILIKON 1000
Applicant
Alcon
PMA number
P950008
Supplement
S003
Product code
LWL
Decision date
2002-01-23
Classification
Fluid, Intraocular
Generic name
Fluid, intraocular
Approval order statement
APPROVAL FOR MODIFICATION OF THE MOLECULAR WEIGHT RANGE SPECIFICATION FOR SILIKON 1000 FROM 36,000 - 48,000 DALTON TO 32,850 - 47,000 DALTON.

Current openFDA PMA Record#

Device
SILIKON 1000
Applicant
Alcon
PMA number
P950008
Supplement
S003
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2002-01-23
Decision code
APPR
Date received
2001-10-04
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATION OF THE MOLECULAR WEIGHT RANGE SPECIFICATION FOR SILIKON 1000 FROM 36,000 - 48,000 DALTON TO 32,850 - 47,000 DALTON.