PMA P200020S006

Device
THIXO
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S006
Product code
MFK
Decision date
2024-07-11
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
changes to the supplier of aluminum powder and to a proprietary polishing compound

Current openFDA PMA Record#

Device
THIXO
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S006
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2024-07-11
Decision code
OK30
Date received
2024-06-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the supplier of aluminum powder and to a proprietary polishing compound