PMA P170039
- Device
- CustomFlex ArtificialIris
- Applicant
- Humanoptics AG
- PMA number
- P170039
- Supplement
- S003
- Product code
- QBT
- Decision date
- 2020-09-04
- Generic name
- Artificial iris
- Approval order statement
- Approval for the addition of a second supplier of saline solution used for filling the artificial iris primary packaging.
Current openFDA PMA Record#
- Device
- CustomFlex ArtificialIris
- Applicant
- Humanoptics AG
- PMA number
- P170039
- Supplement
- S003
- Product code
- QBT
- Generic name
- Artificial iris
- Decision date
- 2020-09-04
- Decision code
- APPR
- Date received
- 2019-09-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a second supplier of saline solution used for filling the artificial iris primary packaging.