SBL-3 Intraocular Lens

FDA Premarket Approval P200020 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceSBL-3 Intraocular Lens
Generic NameLens, Multifocal Intraocular
ApplicantLenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS001 Date Received08/18/2022 Decision Date09/16/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-08-18
Decision Date2022-09-16
PMAP200020
SupplementS001
Product CodeMFK 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressLenstec, Inc.
1765 Commerce Avenue North
st. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS001 Date Received08/18/2022 Decision Date09/16/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Of The Protocol For The Post-approval Study (PAS).

Supplemental Filings

Supplement NumberDateSupplement Type
P200020Original Filing
S001 2022-08-18 Normal 180 Day Track No User Fee

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