PMA P840064S024

Device
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S024
Product code
LZP
Decision date
2003-05-23
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
APPROVAL FOR ADDITION FOR THE FOLLOWING PRECAUTION TO THE PRODUCT INSERT: "USE ONLY IF THE CONTAINER IS UNDAMAGED."

Current openFDA PMA Record#

Device
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S024
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2003-05-23
Decision code
APPR
Date received
2003-04-24
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR ADDITION FOR THE FOLLOWING PRECAUTION TO THE PRODUCT INSERT: "USE ONLY IF THE CONTAINER IS UNDAMAGED."