CustomFlex Artificial Iris
FDA premarket approval P170039 · decided 2018-05-30
Approval details
- PMA number
- P170039
- Trade name
- CustomFlex Artificial Iris
- Generic name
- Artificial iris
- Applicant
- Humanoptics AG
- Date received
- 2017-11-29
- Decision date
- 2018-05-30
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- QBT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Erlangen
- Statement
- Approval for the CustomFlex Artificial Iris. The CustomFlex Artificial Iris is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.
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