IC-8 Apthera Intraocular Lens (IOL)
FDA premarket approval P210005/S007 · decided 2025-04-25
Approval details
- PMA number
- P210005
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- IC-8 Apthera Intraocular Lens (IOL)
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2024-12-06
- Decision date
- 2025-04-25
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- 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
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