PMA P890047S063

Device: PROVISC™ Ophthalmic Viscosurgical Device
Applicant: Alcon Research, Ltd.
PMA number: P890047
Supplement: S063
Product code: LZP
Decision date: 2024-03-27
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: adding an alternate sourcing of five excipients from Alcon’s approved suppliers for the production of OVDs at the Lifecore Biomedical manufacturing site

Current openFDA PMA Record#

Device: PROVISC™ Ophthalmic Viscosurgical Device
Applicant: Alcon Research, Ltd.
PMA number: P890047
Supplement: S063
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2024-03-27
Decision code: OK30
Date received: 2024-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding an alternate sourcing of five excipients from Alcon’s approved suppliers for the production of OVDs at the Lifecore Biomedical manufacturing site