PMA P030028S006
- Device
- Artisan Myopia
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S006
- Product code
- MTA
- Decision date
- 2018-10-23
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the Artisan Myopia Intraocular Lenses sterilized at AT Sterigenics in Belgium.
Current openFDA PMA Record#
- Device
- Artisan Myopia
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S006
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2018-10-23
- Decision code
- OK30
- Date received
- 2018-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the Artisan Myopia Intraocular Lenses sterilized at AT Sterigenics in Belgium.