PMA P200020S002

Device
SBL-3 Multifocal Intraocular Lens
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S002
Product code
MFK
Decision date
2022-11-17
Generic name
Lens, multifocal intraocular
Approval order statement
Approval of the revised protocol for the post-approval study (PAS).

Current openFDA PMA Record#

Device
SBL-3 Multifocal Intraocular Lens
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S002
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2022-11-17
Decision code
APPR
Date received
2022-10-20
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS).