ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL)
FDA premarket approval P030028/S004 · decided 2018-08-20
Approval details
- PMA number
- P030028
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL)
- Generic name
- Lens, intraocular, phakic
- Applicant
- Ophtec BV
- Date received
- 2017-01-31
- Decision date
- 2018-08-20
- Days to decision
- 566 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Approval for modifying the physician and patient labeling to include the results from the new enrollment post-approval study.
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