Artisan Myopia
FDA premarket approval P030028/S010 · decided 2024-11-15
Approval details
- PMA number
- P030028
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Artisan Myopia
- Generic name
- Lens, intraocular, phakic
- Applicant
- Ophtec BV
- Date received
- 2022-03-30
- Decision date
- 2024-11-15
- Days to decision
- 961 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Approval for a manufacturing site located at Sterigenics Germany GmbH, FEI 3006003617, Kasteler Str. 45 Wiesbaden Hesse, 65203, Germany, for Ethylene Oxide Sterilization of Artisan Myopia Intraocular Lens.
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