IC-8® Apthera Intraocular Lens (IOL)
FDA premarket approval P210005/S003 · decided 2022-12-23
Approval details
- PMA number
- P210005
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IC-8® Apthera Intraocular Lens (IOL)
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2022-09-30
- Decision date
- 2022-12-23
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the extension of the expiration dating on product labeling from 6 months to 12 months, and proposed modifications to the protocols for your respective ongoing accelerated and real-time shelf life studies.
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