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PMA P840064S071

Device
DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S071
Product code
LZP
Decision date
2020-04-02
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Use of the Bulk Syringe Line (BSL) as an additional alternate syringe processing and filling line to fill PROVISC, DISCOVISC® and PROVISC® as part of DUOVISC®.

Current openFDA PMA Record#

Device
DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S071
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2020-04-02
Decision code
OK30
Date received
2020-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of the Bulk Syringe Line (BSL) as an additional alternate syringe processing and filling line to fill PROVISC, DISCOVISC® and PROVISC® as part of DUOVISC®.