PMA P990023S014

Device
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S014
Product code
LZP
Decision date
2016-05-18
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.

Current openFDA PMA Record#

Device
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S014
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2016-05-18
Decision code
OK30
Date received
2016-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.