Artisan Myopia
FDA premarket approval P030028/S009 · decided 2022-07-22
Approval details
- PMA number
- P030028
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Artisan Myopia
- Generic name
- Lens, intraocular, phakic
- Applicant
- Ophtec BV
- Date received
- 2022-02-08
- Decision date
- 2022-07-22
- Days to decision
- 164 days
- Decision code
- OK30
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Change to the processing agent used in the milling process for the ARTISAN Myopia.
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