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PMA P840064S068

Device
VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S068
Product code
LZP
Decision date
2018-04-24
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Use of a compounding isolator for sterile incorporation of Sodium Hyaluronate during production of PROVISC and PROVISC as part of DUOVISC, and for additional formulation rooms 4 and 5 for manufacture of PROVISC, PROVISC as part of DUOVISC, VISCOAT, and VISCOAT as part of DUOVISC.

Current openFDA PMA Record#

Device
VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S068
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2018-04-24
Decision code
OK30
Date received
2018-03-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of a compounding isolator for sterile incorporation of Sodium Hyaluronate during production of PROVISC and PROVISC as part of DUOVISC, and for additional formulation rooms 4 and 5 for manufacture of PROVISC, PROVISC as part of DUOVISC, VISCOAT, and VISCOAT as part of DUOVISC.