PMA P890047S065

Device
PROVSIC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S065
Product code
LZP
Decision date
2024-08-12
Classification
Ophthalmic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
moving the particulate testing for PROVISC™ Ophthalmic Viscosurgical Device (OVD), VISCOAT™ OVD, DUOVISC™ OVD, and DISCOVISC™ OVD

Current openFDA PMA Record#

Device
PROVSIC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S065
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2024-08-12
Decision code
OK30
Date received
2024-08-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
moving the particulate testing for PROVISC™ Ophthalmic Viscosurgical Device (OVD), VISCOAT™ OVD, DUOVISC™ OVD, and DISCOVISC™ OVD