PMA P840064S035

Device
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S035
Product code
LZP
Decision date
2008-05-05
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
USE OF AN ALTERNATE ANALYTICAL METHOD FOR THE IDENTIFICATION OF RUBBER FORMULATIONS USED IN THE SYRINGE TIP CAP AND STOPPERS.

Current openFDA PMA Record#

Device
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S035
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2008-05-05
Decision code
OK30
Date received
2008-04-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF AN ALTERNATE ANALYTICAL METHOD FOR THE IDENTIFICATION OF RUBBER FORMULATIONS USED IN THE SYRINGE TIP CAP AND STOPPERS.