PMA P210005S006
- Device
- IC-8 Apthera intraocular lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S006
- Product code
- POE
- Decision date
- 2023-10-30
- Classification
- Ophthalmic
- Generic name
- Extended depth of focus intraocular lens
- Approval order statement
- a change in the outer carton label stock and printer ribbon
Current openFDA PMA Record#
- Device
- IC-8 Apthera intraocular lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S006
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2023-10-30
- Decision code
- OK30
- Date received
- 2023-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the outer carton label stock and printer ribbon