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- MiscellaneousMiscellaneous
- OGOIntraocular Pressure Lowering Implant3Product Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
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CustomFlex Artificial Iris
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- HumanOptics AG
- Trade Name
- CustomFlex Artificial Iris
- Generic Name
- Artificial iris
- Decision Date
- 5/30/2018
- Days to Decision
- 182 days
- Decision Code
- APPR
- FDA Decision
- Approval