CustomFlex ArtificialIris
FDA premarket approval P170039/S003 · decided 2020-09-04
Approval details
- PMA number
- P170039
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CustomFlex ArtificialIris
- Generic name
- Artificial iris
- Applicant
- Humanoptics AG
- Date received
- 2019-09-25
- Decision date
- 2020-09-04
- Days to decision
- 345 days
- Decision code
- APPR
- Product code
- QBT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Erlangen
- Statement
- Approval for the addition of a second supplier of saline solution used for filling the artificial iris primary packaging.
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