PMA P890047S062

Device
PROVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S062
Product code
LZP
Decision date
2023-12-18
Classification
Ophthalmic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
to update sodium hyaluronate (NaHy) raw material test methods

Current openFDA PMA Record#

Device
PROVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S062
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2023-12-18
Decision code
OK30
Date received
2023-11-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to update sodium hyaluronate (NaHy) raw material test methods