IC-8 Apthera IOL Aperture Mask
FDA premarket approval P210005/S009 · decided 2025-03-07
Approval details
- PMA number
- P210005
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IC-8 Apthera IOL Aperture Mask
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2025-02-03
- Decision date
- 2025-03-07
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- adding an alternative aperture mask subcomponent supplier
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