PMA P840064S062

Device
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S062
Product code
LZP
Decision date
2017-10-31
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Approval for a manufacturing site change located at Lifecore Biomedical, LLC., 3515 Lyman Boulevard, Chaska, Minnesota, USA, and Lifecore Biomedical, LLC, 1245 Lakeview Drive, Chaska, Minnesota, USA.

Current openFDA PMA Record#

Device
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S062
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2017-10-31
Decision code
APPR
Date received
2016-07-21
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site change located at Lifecore Biomedical, LLC., 3515 Lyman Boulevard, Chaska, Minnesota, USA, and Lifecore Biomedical, LLC, 1245 Lakeview Drive, Chaska, Minnesota, USA.