PMA P210005S004
- Device
- IC-8 Apthera Intraocular Lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S004
- Product code
- POE
- Decision date
- 2022-12-02
- Generic name
- Extended depth of focus intraocular lens
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- IC-8 Apthera Intraocular Lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S004
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2022-12-02
- Decision code
- APPR
- Date received
- 2022-11-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.