PMA P210005S009
- Device
- IC-8 Apthera IOL Aperture Mask
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S009
- Product code
- POE
- Decision date
- 2025-03-07
- Classification
- Ophthalmic
- Generic name
- Extended depth of focus intraocular lens
- Approval order statement
- adding an alternative aperture mask subcomponent supplier
Current openFDA PMA Record#
- Device
- IC-8 Apthera IOL Aperture Mask
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S009
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2025-03-07
- Decision code
- OK30
- Date received
- 2025-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding an alternative aperture mask subcomponent supplier