Artisan Myopia
FDA premarket approval P030028/S006 · decided 2018-10-23
Approval details
- PMA number
- P030028
- Supplement
- S006
- 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
- 2018-09-18
- Decision date
- 2018-10-23
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the Artisan Myopia Intraocular Lenses sterilized at AT Sterigenics in Belgium.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.