PMA P890047S054

Device
PROVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S054
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
PROVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S054
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®.