PMA P200020S001

Device
SBL-3 Intraocular Lens
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S001
Product code
MFK
Decision date
2022-09-16
Generic name
Lens, multifocal intraocular
Approval order statement
Approval of the protocol for the post-approval study (PAS).

Current openFDA PMA Record#

Device
SBL-3 Intraocular Lens
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S001
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2022-09-16
Decision code
APPR
Date received
2022-08-18
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the protocol for the post-approval study (PAS).