PMA P840064S075

Device
DISCOVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S075
Product code
LZP
Decision date
2021-12-03
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Approval for the alternate manufacturing sites located are: Lifecore Biomedical, LLC (Site 1) 3515 Lyman Boulevard Chaska, MN 55318 and Lifecore Biomedical, LLC (Site 2) 1245 Lakeview Drive Chaska, MN 55318.

Current openFDA PMA Record#

Device
DISCOVISC™ Ophthalmic Viscosurgical Device
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S075
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2021-12-03
Decision code
APPR
Date received
2021-04-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the alternate manufacturing sites located are: Lifecore Biomedical, LLC (Site 1) 3515 Lyman Boulevard Chaska, MN 55318 and Lifecore Biomedical, LLC (Site 2) 1245 Lakeview Drive Chaska, MN 55318.