PMA P950008S011

Device
SILIKON 1000 RETINAL TAMPONADE
Applicant
Alcon
PMA number
P950008
Supplement
S011
Product code
LWL
Decision date
2013-11-22
Classification
Fluid, Intraocular
Generic name
Fluid, intraocular
Approval order statement
ALTERNATE REAGENT SUPPLIER.

Current openFDA PMA Record#

Device
SILIKON 1000 RETINAL TAMPONADE
Applicant
Alcon
PMA number
P950008
Supplement
S011
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2013-11-22
Decision code
OK30
Date received
2013-10-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE REAGENT SUPPLIER.