PMA P990023S009

Device
CELLUGEL
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S009
Product code
LZP
Decision date
2010-06-16
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
USE OF A NEWLY CONSTRUCTED CLEANROOM FOR ASEPTIC COMPOUNDING AND ASEPTIC FILLING PROCESSES.

Current openFDA PMA Record#

Device
CELLUGEL
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S009
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2010-06-16
Decision code
OK30
Date received
2010-05-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF A NEWLY CONSTRUCTED CLEANROOM FOR ASEPTIC COMPOUNDING AND ASEPTIC FILLING PROCESSES.