PMA P170039S002
- Device
- CustomFlex Artificial Iris
- Applicant
- Humanoptics AG
- PMA number
- P170039
- Supplement
- S002
- Product code
- QBT
- Decision date
- 2019-10-03
- Classification
- Artificial Iris
- Generic name
- Artificial iris
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- CustomFlex Artificial Iris
- Applicant
- Humanoptics AG
- PMA number
- P170039
- Supplement
- S002
- Product code
- QBT
- Generic name
- Artificial iris
- Decision date
- 2019-10-03
- Decision code
- APPR
- Date received
- 2018-07-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.