PMA P840064S073

Device: VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S073
Product code: LZP
Decision date: 2020-10-23
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Alternate release testing site for raw materials and primary packaging components in the production of VISCOAT, PROVISC, DUOVISC, and DISCOVISC.

Current openFDA PMA Record#

Device: VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S073
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2020-10-23
Decision code: OK30
Date received: 2020-10-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate release testing site for raw materials and primary packaging components in the production of VISCOAT, PROVISC, DUOVISC, and DISCOVISC.