FDA.reportPublic FDA data

PMA P890047S057

Device
PROVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S057
Product code
LZP
Decision date
2021-03-03
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Introduction of Lifecore Biomedical, LLC Site 2 as a additional quality control laboratory for release and stability chemistry testing of the VISCOAT and PROVISC Ophthalmic Viscosurgical Devices, as well as the DUOVISC Ophthalmic Viscoelastic System.

Current openFDA PMA Record#

Device
PROVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S057
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2021-03-03
Decision code
OK30
Date received
2021-02-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of Lifecore Biomedical, LLC Site 2 as a additional quality control laboratory for release and stability chemistry testing of the VISCOAT and PROVISC Ophthalmic Viscosurgical Devices, as well as the DUOVISC Ophthalmic Viscoelastic System.