CustomFlex Artificial Iris
FDA premarket approval P170039/S002 · decided 2019-10-03
Approval details
- PMA number
- P170039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- CustomFlex Artificial Iris
- Generic name
- Artificial iris
- Applicant
- Humanoptics AG
- Date received
- 2018-07-19
- Decision date
- 2019-10-03
- Days to decision
- 441 days
- Decision code
- APPR
- Product code
- QBT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Erlangen
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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