PMA P890047S056

Device
PROVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S056
Product code
LZP
Decision date
2020-10-23
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Alternate release testing site for raw materials and primary packaging components in the production of VISCOAT, PROVISC, DUOVISC, and DISCOVISC.

Current openFDA PMA Record#

Device
PROVISC Ophthalmic Viscosurgical Device
Applicant
Alcon Research, Ltd.
PMA number
P890047
Supplement
S056
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2020-10-23
Decision code
OK30
Date received
2020-10-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate release testing site for raw materials and primary packaging components in the production of VISCOAT, PROVISC, DUOVISC, and DISCOVISC.