PMA P890047S059

Device
PROVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S059
Product code
LZP
Decision date
2022-09-15
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Change to the blister seal integrity test method for the testing of the OVD blister.

Current openFDA PMA Record#

Device
PROVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S059
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 blister seal integrity test method for the testing of the OVD blister.