Artisan Myopia Intraocular Lens
FDA premarket approval P030028/S008 · decided 2019-05-14
Approval details
- PMA number
- P030028
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Artisan Myopia Intraocular Lens
- Generic name
- Lens, intraocular, phakic
- Applicant
- Ophtec BV
- Date received
- 2019-02-06
- Decision date
- 2019-05-14
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Approval for minor labeling changes for the Physicians Labeling and Patient Brochure.
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