- Device
- IC-8 Apthera Intraocular Lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S007
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2025-04-25
- Decision code
- APPR
- Date received
- 2024-12-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for updating the Instructions for Use of the IC-8 Apthera Intraocular Lens (IOL) to include the outcomes of the Continuation Post-Approval Study (PAS) SAIL-101-PAS