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.
| Device | SBL-3 Intraocular Lens |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Lenstec, 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 Received | 2022-08-18 |
| Decision Date | 2022-09-16 |
| PMA | P200020 |
| Supplement | S001 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Lenstec, 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). |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200020 | Original Filing | |
| S002 | 2022-10-20 | Normal 180 Day Track No User Fee |
| S001 | 2022-08-18 | Normal 180 Day Track No User Fee |