PMA P840064S070

Device
Ophthalmic Viscosurgical Devices
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S070
Product code
LZP
Decision date
2019-03-20
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Approval for use of the Bulk Syringe Line (BSL) as an additional alternate syringe processing and filling line to fill VISCOAT® and VISCOAT® as part of DUOVISC®

Current openFDA PMA Record#

Device
Ophthalmic Viscosurgical Devices
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S070
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2019-03-20
Decision code
APPR
Date received
2018-08-07
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for use of the Bulk Syringe Line (BSL) as an additional alternate syringe processing and filling line to fill VISCOAT® and VISCOAT® as part of DUOVISC®