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 | IC-8 Apthera Intraocular Lens (IOL) |
| Generic Name | Extended Depth Of Focus Intraocular Lens |
| Applicant | AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS001 Date Received08/23/2022 Decision Date09/20/2022 Product Code POE Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-08-23 |
| Decision Date | 2022-09-20 |
| PMA | P210005 |
| Supplement | S001 |
| Product Code | POE |
| 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 | AcuFocus, Inc. 32 Discovery suite 200 irvine, CA 92618 PMA NumberP210005 Supplement NumberS001 Date Received08/23/2022 Decision Date09/20/2022 Product Code POE 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) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P210005 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210005 | Original Filing | |
| S004 | 2022-11-04 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2022-08-23 | Normal 180 Day Track No User Fee |
| S001 | 2022-08-23 | Normal 180 Day Track No User Fee |