PMA P990023S017

Device
CELLUGEL OVD
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S017
Product code
LZP
Decision date
2022-09-15
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Change to the pouch seal integrity test method for the testing of the CELLUGEL OVD pouch.

Current openFDA PMA Record#

Device
CELLUGEL OVD
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S017
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2022-09-15
Decision code
OK30
Date received
2022-08-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the pouch seal integrity test method for the testing of the CELLUGEL OVD pouch.