PMA P030028S009
- Device
- Artisan Myopia
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S009
- Product code
- MTA
- Decision date
- 2022-07-22
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Change to the processing agent used in the milling process for the ARTISAN Myopia.
Current openFDA PMA Record#
- Device
- Artisan Myopia
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S009
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2022-07-22
- Decision code
- OK30
- Date received
- 2022-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the processing agent used in the milling process for the ARTISAN Myopia.