PMA P990023

Device
CELLUGEL® Ophthalmic Viscosurgical Devices
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S018
Product code
LZP
Decision date
2022-09-22
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Additional release testing site for the primary and secondary packaging components used in the production of CELLUGEL OVD.

Current openFDA PMA Record#

Device
CELLUGEL® Ophthalmic Viscosurgical Devices
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S018
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2022-09-22
Decision code
OK30
Date received
2022-08-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Additional release testing site for the primary and secondary packaging components used in the production of CELLUGEL OVD.