PMA P840064S061

Device
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S061
Product code
LZP
Decision date
2016-05-18
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.

Current openFDA PMA Record#

Device
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S061
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2016-05-18
Decision code
OK30
Date received
2016-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.