IC-8 Apthera Intraocular Lens (IOL)
FDA premarket approval P210005/S004 · decided 2022-12-02
Approval details
- PMA number
- P210005
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- IC-8 Apthera Intraocular Lens (IOL)
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2022-11-04
- Decision date
- 2022-12-02
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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