PMA P840064S059

Device: VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S059
Product code: LZP
Decision date: 2015-04-10
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL TO REPLACE THE CURRENT PRODUCT RELEASE INTRAVITREAL TEST WITH THE INFLAMMATORY RELEASE ASSAY (IRA) PRODUCT RELEASE TEST.

Current openFDA PMA Record#

Device: VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S059
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2015-04-10
Decision code: APPR
Date received: 2015-01-23
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO REPLACE THE CURRENT PRODUCT RELEASE INTRAVITREAL TEST WITH THE INFLAMMATORY RELEASE ASSAY (IRA) PRODUCT RELEASE TEST.